Clinical trial NCT02161705
Conditions: Postoperative Pain Postoperative Nausea and Vomiting Quality of Life
Keywords: Immediate breast reconstruction pain control post mastectomy pain control
Sponsor: Johns Hopkins University
Start date: 2014-07-01; Completion date: 2019-02-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of surgery while the patient is still hospitalized (post-operative day 0). This will be patient-provided data. Unblinded data analysis will compare scores between treatment and control groups.

Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea, and sleep interference differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

Pain score, opioids use, nausea, and sleep interference data will be collected via patient self-report. When possible (i.e., while hospitalized) objective data on opioids and other pain medication administered to the patient will be used.

Tertiary Objectives To determine if long-term changes in Quality of Life scores \[the RAND-36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores\] differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

This data will be collected via validated questionnaires through patient interviews at 3-months, 2-years, and 4-years (±14 days) after surgery.

Once enrolled in the study, participants will be encouraged to remain in the study for the 4 years following surgery in order to get final pain scores and quality-of-life/health outcome survey information. Participants who cannot be contacted after several phone attempts and the sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year outcome assessments will be considered lost to follow-up.

Detailed description:
This double-blind, randomized, controlled clinical trial comparing patient-reported pain and pain medication/narcotic use between patients randomized to treatment (ropivacaine) or placebo (saline) delivered via paravertebral block to the mastectomy site. Candidates will have chosen to have a mastectomy on one side immediately followed with tissue expander placement breast reconstruction.

Patients will be randomized 1:1 to ropivacaine- (treatment) or saline-(placebo) paravertebral blocks in a double-blinded design. Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-operative pain, pain medication/opioid use, and the occurrence of adverse events (AEs)/serious adverse events (SAEs) will be assessed on Days 1, 2, and 3. A clinic visit occurs on Day 7 when additional data are collected (updated medical history, pain medication/opioid use, AEs/SAEs, and study questionnaires. Using two pain scales, the Patient Pain Assessment Questionnaire (Appendix A) and Subjective Pain Survey (Appendix B), the post-operative pain will be compared between treatment and control groups. Differences in opioids use between groups at different time points will also be assessed as a more objective measure of post-operative pain.

Long-term quality-of-life/health outcomes assessments will be done on post-operative Day 90 (±14 days), Year 2 (±14 days), and Year 4 (±14 days). The Year 2 and Year 4 follow-ups are included as tertiary endpoints to capture differences in chronic pain, and patients will be asked to complete the same questionnaires as at the Day 90 follow up.

The investigators hypothesize that post-operative static pain scores will be lower in ropivacaine patients vs. placebo patients in women undergoing mastectomy and immediate reconstruction with placement of tissue expanders. We believe that post-operative moving pain scores, opioids use, nausea, and sleep interference will be likewise improved. We further hypothesize that this decreased post-operative pain may lead to improvements in long-term health outcomes as measured by validated questionnaires. In the presence of clear need and lack of published studies regarding this precise patient population, it is important to determine if paravertebral blocks do reduce post-operative pain, and improve opioids use, nausea, sleep interference, and length of hospital stay in patients undergoing immediate tissue expander breast reconstruction.

Arms: arm 1: Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg). arm 2: Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner.
Interventions: intervention 1: Ropivacaine intervention 2: Saline
Intervention descriptions: intervention 1: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block intervention 2: Up to 0.8 mL/kg of normal saline administered

Protocol documents:
Prot_SAP_001.pdf: 
Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: IRB00210011 
Date: September 11, 2019 
 
 
 
 
 
 
 
Version:  September 11, 2019 
 
Page 1 
 
Pre-operative Paravertebral Blocks to Decrease Post-operative Pain Following 
Mastectomy with Immediate Tissue Expander Reconstruction 
 
JHM IRB 00075957 
   NCT02161705 
 
 
 
Principal Investigator 
Gedge D. Rosson, M.D. 
 
 
 
 
Associate Professor, Plastic Surgery and Oncology 
Department of Plastic and Reconstructive Surgery 
The Johns Hopkins Hospital Outpatient Center 
601 N. Caroline Street, McElderry 8161 
Baltimore, MD 21287 
Phone: 410-955-9477 
Fax: 410-614-1296 
Email:  gedge@jhmi.edu 
 
 
Co-Investigators  
 
Jason C. Brookman, M.D. 
 
 
 
 
Carisa Cooney, MPH, CCRP 
 
 
 
 
Laura Gavin, M.S. 
 
 
 
 
Marcelo Lacayo-Baez, M.D. 
 
 
 
 
Pablo Baltodano, M.D. 
 
 
 
 
Michele Manahan, M.D. 
 
 
 
 
Justin Sacks, M.D. 
 
Research Manager 
 
Carisa M. Cooney, M.P.H., C.C.R.P. 
 
 
 
 
 
 
 
Study Coordinators  
Charalampos Siotos, M.D. 
 
 
 
 
 
 
Study Pharmacist 
Andrea Weiss, R.Ph. 
 
Research Nurse 
Laura Gavin, M.S., C.R.N.P. 
 
 
 
 
 
Note: This is a modified version of the IRB-approved Bupivacaine Pain Pump Study  
JHM IRB# NA_00010363  


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 2 
 
 
Use of Pre-operative Paravertebral Blocks to Decrease Post-operative Pain 
Following Mastectomy with Immediate Tissue expander Reconstruction 
 
 
Original Protocol: 
 
June 25, 2013 
 
Current Protocol:                    September 11, 2013 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 3 
Table of Contents 
 
1. 
PROTOCOL SUMMARY .................................................................................................................................. 6 
2. 
SCHEMA .............................................................................................................................................................. 8 
3. 
RATIONALE ....................................................................................................................................................... 9 
4. 
OBJECTIVES .................................................................................................................................................... 11 
4.1 
PRIMARY OBJECTIVE ..................................................................................................................................... 11 
4.2 
SECONDARY OBJECTIVES ............................................................................................................................... 11 
4.3 
TERTIARY OBJECTIVES .................................................................................................................................. 11 
5. 
INVESTIGATIONAL PLAN ........................................................................................................................... 11 
5.1 
SUMMARY OF STUDY DESIGN ........................................................................................................................ 11 
5.2 
PATIENT POPULATION & INCLUSION/EXCLUSION CRITERIA .......................................................................... 12 
5.3 
INCLUSION OF WOMEN AND MINORITIES ....................................................................................................... 13 
5.4 
DETERMINATION OF ELIGIBILITY ................................................................................................................... 13 
5.5 
RANDOMIZATION ........................................................................................................................................... 13 
5.6 
BLINDING ....................................................................................................................................................... 13 
5.7 
TREATMENT ADMINISTRATION ...................................................................................................................... 14 
5.8 
JUSITIFICATION FOR PLACEBO .……………………………………………………………………………..14 
5.9  DOSE MODIFICATIONS ................................................................................................................................... 14 
5.10 SUPPORTIVE CARE GUIDELINES ..................................................................................................................... 14 
5.11   DURATION OF STUDY PARTICIPATION ........................................................................................................... 14 
6. 
STUDY CALENDAR ........................................................................................................................................ 15 
7. 
PHARMACEUTICAL INFORMATION ........................................................................................................ 16 
7.1 
ROPIVACAINE (NAROPIN) ............................................................................................................................ 16 
7.2 
PLACEBO ........................................................................................................................................................ 22 
7.3 
OPIOID USE .................................................................................................................................................... 23 
8. 
ADMINISTRATIVE PROCEDURES ............................................................................................................. 24 
8.1 
PROTOCOL AMENDMENTS.............................................................................................................................. 24 
8.2 
INFORMED CONSENT ...................................................................................................................................... 24 
8.3 
ETHICS AND GOOD CLINICAL PRACTICE ........................................................................................................ 24 
9. 
ADVERSE EVENTS ......................................................................................................................................... 24 
9.1 
GENERAL ....................................................................................................................................................... 24 
9.2 
DEFINITIONS .................................................................................................................................................. 25 
9.3 
RELATIONSHIP ............................................................................................................................................... 25 
9.4 
REPORTING PROCEDURES .............................................................................................................................. 26 
9.5 
DATA AND SAFETY MONITORING .................................................................................................................. 27 
9.6 
DATA MANAGEMENT ..................................................................................................................................... 27 
9.7 
SAFETY MEETINGS ........................................................................................................................................ 27 
9.8 
MONITORING ................................................................................................................................................. 27 
10. 
STATISTICAL CONSIDERATIONS ........................................................................................................... 28 
10.1 
OBJECTIVES ................................................................................................................................................. 27 
10.2 
STUDY DESIGN ............................................................................................................................................ 29 
10.3 
SAMPLE SIZE AND ACCRUAL ....................................................................................................................... 29 
 
REFERENCES .......................................................................................................................................................... 29 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 4 
 
APPENDICES ............................................................................................................................................................ 31 
APPENDIX A:  PATIENT PAIN ASSESSMENT QUESTIONNAIRE ................................................................................... 32 
APPENDIX B:  SUBJECTIVE PAIN SURVEY ................................................................................................................ 37 
APPENDIX C: BREAST-Q© RECONSTRUCTION MODULE – PREOPERATIVE QUESTIONNAIRE ................................. 38 
APPENDIX D: BREAST-Q© RECONSTRUCTION MODULE –POSTOPERATIVE QUESTIONNAIRE ............................... 41 
APPENDIX E:  RAND-36 ITEM SHORT FORM SURVEY ............................................................................................. 50 
APPENDIX F:  QUICK DASH QUESTIONNAIRE ......................................................................................................... 54 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 5 
 
List of Abbreviations 
 
 
 
ADR 
Adverse Drug Reaction 
AE 
Adverse Event/Adverse Experience 
cc 
Cubic Centimeter 
CNS 
Central Nervous System 
CRF 
Case Report Form 
DASH 
Disability of the Arm, Shoulder, and Hand 
DATA 
Device and Technique Assessment 
DIEP 
Deep Inferior Epigastric Perforator 
HIPAA 
Health Information Portability and Accountability Act 
ICH 
International Conference on Harmonization 
ID 
Identification 
IRB 
Institutional Review Board 
IV 
Intravenous 
mg 
Milligram 
mL 
Milliliter 
PCA 
Patient-Controlled Analgesia 
PO 
By Mouth (Latin: Per os) 
POE 
Provider Order Entry (System) 
PSEF 
Plastic Surgery Education Foundation 
PSI 
Pounds per Square Inch 
RAND 
Research and Development 
SAE 
Serious Adverse Event 
SEER 
Surveillance, Epidemiology, and End Results 
TRAM 
Transverse Rectus Abdominus Myocutaneous 
 
 
 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 6 
 
1. Protocol Summary 
 
 
Full Title 
Use of Pre-operative Paravertebral Blocks to Decrease Post-operative Pain 
Following Mastectomy with Immediate Tissue Expander Reconstruction 
Short Title 
Paravertebral Blocks to Decrease Breast Reconstruction Pain 
Study Type 
Prospective, Randomized, Double-Blind Clinical Trial 
Conducted By 
The Department of Plastic and Reconstructive Surgery 
Johns Hopkins University School of Medicine 
Principal 
Investigator 
Gedge D. Rosson, M.D. 
Sample Size 
Enrolled: 70 (Randomization Treatment: Placebo = 35:35) 
Study Population 
• Women aged 18-75 years. 
• Choose bilateral mastectomy followed by immediate tissue expander 
breast reconstruction. 
• Have no inflammatory breast cancers. 
• Be aware of the nature of her malignancy. 
• Understand the study purpose, requirements, and risks. 
• Be able and willing to give informed consent. 
Accrual Period 
Two Years 
Study Design 
Double-blind, randomized, controlled clinical trial comparing patient-
reported pain and pain medication/opioid use between patients randomized 
to ropivacaine (treatment) pre-operatively placed paravertebral blocks or 
subcutaneous paravertebral saline (placebo) injections. Candidates will 
have elected to undergo bilateral post-mastectomy immediate tissue 
expander breast reconstruction. Participants meeting inclusion criteria will 
be enrolled and baseline data collection completed prior to randomization 
and surgery.  
 
Patients will be randomized 1:1 to ropivacaine- (treatment) paravertebral 
blocks or subcutaneous saline-(placebo) paravertebral injections in a 
double-blinded design. Patient-specific surgical details will be recorded 
intraoperatively. Following the surgery, post-operative pain, pain 
medication/opioid use, and the occurrence of adverse events (AEs)/serious 
adverse events (SAEs) will be assessed on Days 1, 2, and 3. A clinic visit 
occurs on Day 7 when additional data are collected (updated medical 
history, pain medication/opioid use, AEs/SAEs, and study questionnaires).  
  
Long-term quality-of-life/health outcomes assessments will be done on 
post-operative Day 90 (±14 days), Year 2 (±14 days), and Year 4 (±14 
days). The Year 2 and Year 4 follow-ups are included as tertiary endpoints 
to capture differences in chronic pain, and patients will be asked to 
complete the same questionnaires as at the Day 90 follow up. 
Study Duration 
Four years from initial qualifying surgery. 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 7 
Study 
Agent/Intervention 
Description 
Ropivacaine (treatment) pre-operatively placed paravertebral blocks or 
subcutaneous paravertebral saline (placebo) injections. 
Primary Objective 
 
To determine if post-operative static pain scores differ between women 
undergoing bilateral mastectomy followed by bilateral immediate tissue 
expander breast reconstruction randomized either to ropivacaine- 
(treatment) pre-operatively placed paravertebral blocks or subcutaneous 
paravertebral saline (placebo) injections. 
Secondary 
Objectives 
To determine if post-operative moving pain scores, opioid use, nausea, 
sleep interference and length of hospital stay differ between women 
undergoing bilateral mastectomy followed by bilateral immediate tissue 
expander breast reconstruction randomized either to ropivacaine- 
(treatment) pre-operatively placed paravertebral blocks or subcutaneous 
paravertebral saline (placebo) injections. 
Tertiary 
Objectives 
To determine if long-term changes in Quality of Life scores [the RAND-
36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick 
DASH) questionnaire, and Breast-Q scores] differ between women 
undergoing bilateral mastectomy followed by bilateral immediate tissue 
expander breast reconstruction randomized either to ropivacaine- 
(treatment) pre-operatively placed paravertebral blocks or subcutaneous 
paravertebral saline (placebo) injections. 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 8 
 
2. Schema 
 
Post-operative 
Assessment
Pain Medication 
Monitoring
Health reassessment 
with surveys and 
questionnaires
Baseline Assessment
Baseline static and moving pain scores
Nausea and sleep interferences scores
RAND 36 Health Survey (RAND 36)
Disability of the Arm, Shoulder and Hand 
questionnaire (Quick DASH)
Pre-operative Breast-Q
General health assessment completion
Eligible Subjects
Breast Cancer Patients undergoing bilateral immediate tissue expander reconstruction following bilateral mastectomy
Consent (n = 70)
Randomization
Placebo
(n = 35)
Ropivacaine
(n = 35)
Post-operative 
Assessment
Pain Medication 
Monitoring
Health reassessment 
with surveys and 
questionnaires


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 9 
 
3. Rationale 
Immediate breast reconstruction following mastectomy, when compared with delayed 
reconstruction or no reconstruction, has been shown to have superior results for both aesthetics 
and psychometric outcomes1,2, and is less expensive than delayed breast reconstruction.3 
Additionally, the type of breast reconstruction (implant versus autologous) can affect 
psychosocial outcomes.4 However, the percentage of patients who undergo immediate 
reconstruction following mastectomy for breast cancer remains low.  The national average from 
the SEER database in 1998 was 15%5, while an evaluation of the Maryland Hospital Discharge 
Database for 1995 through 2005 found that 28% of women in the state of Maryland had 
immediate breast reconstruction following mastectomy.6 These low rates may be because 
patients who have mastectomy and immediate placement of tissue expanders for reconstruction 
have much more pain than patients who have mastectomy alone.7  
 
Finding appropriate and safe ways to control post-operative pain is important. While adding non-
steroidal anti-inflammatory drugs can decrease pain, it seems to increase complications. A 
randomized trial has shown that diclofenac significantly decreases pain and opioid use following 
mastectomy and immediate breast reconstruction, but significantly increases bleeding.8  
 
One randomized, placebo-controlled, blinded trial found significant reductions in pain scores and 
analgesic consumption as well as earlier return to normal activity and better surgeon and patient 
satisfaction when preoperative paravertebral blockade with bupivacaine was given along with 
general anesthesia for varicocelectomy surgery.9 A randomized, blinded trial in the setting of 
Video Assisted Thoracic Surgery, showed significant reductions on postoperative pain scores, 
decreased cumulative morphine consumption, increased patient satisfaction with analgesia and 
quicker first mobilization and time to hospital discharge.10 Similarly, two prospective, 
randomized placebo-controlled trials (in the settings of hepatectomy11 and retropubic 
prostatectomy12) also showed similar results. Further, at least six prospective randomized trials 
across several surgical procedures and specialties.13, 14, 15, 16, 17, 18 have also shown a significant 
improvement in postoperative pain with the application of concomitant paravertebral block for 
analgesia. Some of these trials report on decreased consumption of postoperative analgesics16, 14 
earlier discharge17, 18 and decreased likelihood of complications.15 
 
In terms of breast surgery, paravertebral blocks have been studied at the breast site mostly after 
mastectomy. We found two randomized, double-blinded, placebo-controlled trials focused on the 
mastectomy-only (i.e., no reconstruction) patient population. One of them, by Buckenmaier et 
al., studied 73 unilateral mastectomy patients and concluded that routine use of a continuous 
paravertebral block catheter for anesthesia was not supported due to a lack of clinical 
significance in degree of postoperative pain, nausea, mood state, level of symptom distress, or 
return to normal activity among the study groups.19 The second paper, by Moller et al., studied 
88 unilateral mastectomy patients with one-time multi-level bupivacaine paravertebral block, but 
found no statistical difference in pain scores or consumption of analgesics between the study and 
control groups.20 We also found one prospective, randomized trial that included patients with 
lumpectomy and mastectomy.21 This study by Pusch et al. found that single-injection 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 10 
paravertebral blocks were quite beneficial and could be used as an alternative to general 
anesthesia. 
 
We also found two retrospective chart reviews that included tissue expander breast 
reconstruction patients within their study populations.22, 23 One of these studies concluded 
retrospectively that paravertebral blocks in immediate breast reconstruction with tissue 
expanders may play an important role for decreasing pain and analgesic usage.22 Overall, these 
two studies supported the use of paravertebral blocks for analgesia in the breast surgery and 
breast reconstruction patient population.21, 22, 23 Additionally, Coopey et al. concluded 
retrospectively that preoperative paravertebral blocks in patients undergoing mastectomy 
followed by immediate reconstruction with tissue expanders or implants significantly reduced 
length of hospital stay, postoperative nausea and shortened the mean time to conversion to oral 
opioids.24 Our current proposal is built upon preliminary data gathered from our institution 
(Table 1). Collectively, patients who received mastectomy-tissue expander reconstruction whom 
were not offered pre-operative paravertebral block, reported higher incidence of pain complaints 
during inpatient stay (Table 2).  However, we did not find any prospective report focused solely 
on the use of paravertebral blocks for analgesia in breast reconstruction with tissue expanders, 
implants or flaps. 
 
Table 1: Number of patients who received pre-operative paravertebral block according to site of breast 
reconstruction from year 2011-2012 
Breast reconstruction site 
Paravertebral block (n) 
No paravertebral block (n) 
Left 
9 
19 
Right 
9 
18 
Bilateral 
9 
24 
Total patients 
27 
61 
 
Table 2: Analysis of outcome with descriptive statistics  
Patient cohorts 
Postoperative pain 
event (P-value) 
Duration of inpatient stay 
(P-value) 
Postoperative nausea or 
vomiting (P-value) 
PVB  vs non-PVB (Total) 
0.039 
0.17 
0.81 
PVB vs non-PVB  
(Unilateral reconstruction)  
0.132 
0.19 
0.75 
PVB vs non-PVB 
(Bilateral reconstruction ) 
0.423 
0.12 
0.23 
* P-value of <0.05 is considered significant.  
PVB = Paravertebral block 
 
Moreover, to date, we do not know of any prospective, randomized placebo-controlled 
trials reported in tissue expander-based breast reconstruction patients. In fact, the PSEF 
Device and Technique Assessment (DATA) committee issued a call for prospective, randomized 
implanted bupivacaine pain pump studies in 2006.25 We believe, therefore, that prospective, 
randomized, double blind trials are still warranted to confirm the efficacy and safety of 
continuous bupivacaine infusion via a pain pump in plastic surgery patients. The innovation of 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 11 
our study is that paravertebral blocks are similar in philosophy to the pain pumps, but less 
expensive and with lower risk of infection. 
 
We hypothesize that post-operative static pain scores will be lower in ropivacaine patients vs. 
placebo patients in women undergoing bilateral mastectomy and bilateral immediate 
reconstruction with placement of tissue expanders.  We believe that post-operative moving pain 
scores, opioids use, nausea, and sleep interference will be likewise improved.  We further 
hypothesize that this decreased post-operative pain may lead to improvements in long-term 
health outcomes as measured by validated questionnaires.   In the presence of clear need and lack 
of published studies regarding this precise patient population, it is important to determine if 
paravertebral blocks do reduce post-operative pain, and improve opioids use, nausea, sleep 
interference, and length of hospital stay in patients undergoing immediate tissue expander breast 
reconstruction. 
4. Objectives 
4.1 
Primary Objective 
To determine if post-operative static pain scores differ between women undergoing bilateral 
mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized 
either to ropivacaine- (treatment) pre-operatively placed paravertebral blocks or subcutaneous 
paravertebral saline (placebo) injections. 
4.2 
Secondary Objectives 
To determine if post-operative moving pain scores, opioid use, nausea, sleep interference, and 
length of hospital stay differ between women undergoing bilateral mastectomy followed by 
bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine- 
(treatment) pre-operatively placed paravertebral blocks or subcutaneous paravertebral saline 
(placebo) injections.   
4.3 
Tertiary Objectives 
To determine if long-term changes in Quality of Life scores [(the RAND-36 Health Survey, 
Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores)] 
differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue 
expander breast reconstruction randomized either to ropivacaine- (treatment) pre-operatively 
placed paravertebral blocks or subcutaneous paravertebral saline (placebo) injections. 
5. Investigational Plan 
5.1 
Summary of Study Design 
Participants meeting inclusion criteria will be enrolled and baseline data collection completed 
prior to randomization and surgery. Baseline data collection includes a general patient history, 
the Patient Pain Assessment Questionnaire which includes static and moving pain scores as well 
as nausea and sleep interference scores (Appendix A), the Subjective Pain Survey (Appendix B), 
the pre-operative Breast-Q (Appendix C), the RAND-36 (Appendix E), and the Quick DASH 
survey (Appendix F).   
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 12 
Patients will be randomized 1:1 to ropivacaine- (treatment) pre-operatively placed paravertebral 
blocks or subcutaneous paravertebral saline (placebo) injections in a double-blinded design. 
Neither the treatment team (the anesthesiologist and the surgeon) nor the patient will know the 
randomization assignment. The pharmacy will be unmasked. 
 
Patient-specific surgical details will be recorded intraoperatively. Following the surgery, post-
operative pain [(measured by the Patient Pain Assessment Questionnaire (Appendix A)], pain 
medication/opioid use, and the occurrence of adverse events (AEs)/serious adverse events 
(SAEs) will be assessed routinely by staff during the hospital stay and on Days 2 and 3 by 
telephone interview with study staff for discharged patients. The typical post-operative length of 
hospital stay is approximately one day. Participants are to return to clinic for the Day 7 (±2 days) 
follow-up visit. At this visit an updated medical history will be completed, pain 
medication/opioid use recorded, and participant AEs/SAEs assessed. Additionally, participants 
will complete the following questionnaires: Patient Pain Assessment, RAND-36, and Quick 
DASH. 
  
Long-term quality-of-life/health outcomes assessments will be done on post-operative Day 90 
(±14 days), Year 2 (±14 days), and Year 4 (±14 days).  During the Day 90 visit, pain scores 
(Patient Pain Assessment Questionnaire), pain medication/opioid use, post-operative Breast-Q, 
RAND-36, and the Quick DASH will be administered. The Year 2 and Year 4 follow-ups are 
included as tertiary endpoints to capture differences in chronic pain, and patients will be asked to 
complete the same questionnaires as at the Day 90 follow up. 
5.2 
Patient Population 
All patients presenting to the Johns Hopkins Avon Foundation Breast Center for surgical 
management of high risk for breast cancer, pre-malignant breast lesions, or breast cancer leading 
to bilateral mastectomies with reconstruction will be evaluated for participation.  Those meeting 
inclusion criteria and no exclusion criteria may be enrolled into the study. 
5.2.1 Inclusion Criteria 
Eligible participants must  
• Be Female aged 18-100 years. 
• Choose bilateral mastectomy followed by bilateral immediate tissue expander breast 
reconstruction. 
• Have no inflammatory breast cancers. 
• Be aware of the nature of her malignancy. 
• Understand the study purpose, requirements, and risks. 
• Be able and willing to give informed consent. 
5.2.2 Exclusion Criteria 
Participants with the following conditions will be ineligible: 
• Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible). 
• Liver dysfunction and/ or cirrhosis. 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 13 
• Renal insufficiency, with creatinine greater than 1.5 mg/mL. 
•    Patients weighing less than 50 Kg. 
•    Concurrent use of the SSRI antidepressant fluvoxamine (Luvox). 
Having a tattoo on the back that is too large to permit PVB injections (as determined by the 
provider performing the procedure). 
5.3 
Inclusion of Women and Minorities 
This study is open to accrual of women only.  Individuals of all races and ethnic groups are 
eligible for this trial.  There is no bias towards age or race in the clinical trial outlined.   
5.4 
Determination of Eligibility 
Potential subjects will be consented by the study investigators or study staff.  If determined 
eligible, subjects will be registered with the study coordinator through the assignment of a study-
specific ID number.    
5.5 
Randomization 
During the study, patients desiring a bilateral mastectomy followed by bilateral immediate tissue 
expander reconstruction will be randomized to ropivacaine- pre-operatively placed paravertebral 
blocks or subcutaneous paravertebral saline (placebo) injections at the same site as the 
paravertebral block.  Randomization will be performed by the pharmacy when the medication is 
requested prior to paravertebral block administration.  
 
A master list of randomization assignments made by the protocol biostatistician will be delivered 
to the Research Pharmacy at Johns Hopkins. Other key personnel may also receive this list, if 
required.  
5.6 
Blinding 
Both patients and the treating anesthesiologist(s) will be blinded as to whether the patients are 
receiving a ropivacaine (treatment) or saline (placebo) solution through the Day 90 visit. One 
anesthesiologist (who is also a co-investigator), which will not be involved with the intra- and 
postoperative patient care and data collection, will perform all the paravertebral blocks and sham 
procedures. The anesthesiologists managing intra- and postoperative patient care and all data 
collection will be unaware of the group assignment. Postoperative assessments will be performed 
by anesthesiologists who will be blinded to each patient’s group. This strategy will allow a 
double-blinded design. Blinding the study will help to reduce the chance of bias in subjective 
outcomes such as pain scores and quality-of-life scores. Once all enrolled patients have 
completed their Day 90 visit, unblinding will occur for study staff to enable data analysis. 
Patients will have the option of learning their treatment assignment group once they have 
completed their Year 4 follow-up interview.  
 
In case of an emergency when the treating investigator deems identification of the study drug 
necessary for the purpose of providing urgent patient care, and knowledge of the subject’s 
treatment assignment will alter subsequent care, then the investigator is authorized to break the 
blind.  In order to learn of the randomization assignment, the Principal Investigator or designee 
will contact the Research Pharmacy to request treatment assignment information.  


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5.7 
Treatment Administration 
The randomized treatment assignment will be prepared by the pharmacy.  Upon arrival to the 
operating room, standard vital sign monitors will be placed and the patient will be positioned in 
the sitting position.  After administering light sedation with low-dose midazolam and fentanyl, 
the skin of the back will be cleaned with chlorhexidine antiseptic.  Local anesthesia of the skin, 
subcutaneous tissue and periosteum of the transverse processes 2.5-cm lateral to each side of the 
thoracic spine (T2-T8) will be performed using 2–5 ml of lidocaine 10 mg/ml. The paravertebral 
block injections of study solution will occur using the landmark-based classic or ultrasound-
guided technique with a 22-guage Tuohy needle.  Double-blinding of patients (study subjects) 
and physicians/the study team will be maintained, unless it becomes critically necessary to break 
double-blinding randomization for medical care. One-half of patients will get subcutaneous 
injectable normal saline (3 to 5 mL at each of 14 injections sites), and one-half will get 0.5% 
ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg).   Immediately after completion of the 
paravertebral injections or subcutaneous injections, the patients will be repositioned supine and 
general anesthesia induced in the standard manner.  All patients will also receive Fentanyl 1.5 
mcg/kg 5-10 minutes prior to surgical incision.  The primary anesthesia team in the operating 
room caring for the patient will not be involved in preparation, randomization, or block 
placement. 
The standard orders for the PCA pump and opioid are per the currently used Sunrise POE order 
set for plastic surgery patients. No changes will be made to the standard administration of 
anesthesia or to currently available postoperative orders. 
5.8 
Justification For Placebo 
In clinical trials of surgical interventions, sham procedure is an important scientific control. The 
sham paravertebral subcutaneous saline injections will contribute to isolate the specific effects of 
the treatment drug (ropivacaine hcl) as opposed to the patient's perception of having had a 
regular paravertebral block. Thus, sham paravertebral subcutaneous saline injections serve an 
analogous purpose to placebo drugs, neutralizing biases such as the placebo effect. Additionally, 
the subcutaneous paravertebral injections of placebo (normal saline) do not carry increased risks 
besides the potential risks of the injection process itself. The potential risks associated with the 
injection process itself include the risk of inadvertent vascular puncture (6.8%), pleural puncture 
(0.8%) and pneumothorax (0.5%),26 all of which are classified as unlikely events (occurring in 1-
10 of every 100 patients). Hence, the administration of placebo will strengthen the study design 
and any conclusion reached without significantly increasing the risk of complications. 
5.9 
Dose Modifications 
The administration of the blocks will be ceased if the patient is experiencing any unanticipated 
adverse events (i.e., worse side effects than predicted). (See section 7.1.7 for potential side 
effects.)  
5.10 Supportive Care Guidelines 
In general, concomitant medications and therapies deemed necessary for the supportive care and 
safety of the subject are allowed, provided their use is documented in the medical records and 
followed up through the Day 7 post-operative visit.   


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5.11 Duration of Study Participation 
Study participation continues through Year 4 post-operatively. However, the majority of data 
collection will occur during the first 7 days after the participant’s immediate tissue expander 
reconstruction following mastectomy. An additional study visit will occur in clinic at Day 90 
(±14 days), prior to the participant’s undergoing any additional reconstructive breast surgery 
procedures. Thereafter, follow-up phone interviews will occur at post-operative Year 2 (±14 
days), and post-operative Year 4 (±14 days). 
 
Participants are to return to clinic for a Day 90 (±14 days) follow-up visit. To encourage 
participation, participant parking and a $15 gift card will be given (or mailed) to participants who 
complete the Day 90 visit. 
 
If a participant chooses to withdraw, is withdrawn, or refuses to participate through Day 90, all 
efforts will be made to collect all Day 90 post-operative data at the time of study withdrawal. 
Reasons for premature participation/treatment withdrawal will be recorded to the best of the 
study team’s ability. Reasons for early withdrawal may include the following: 
 
1. Unanticipated or serious adverse events. 
2. Inter-current illness that prevents further administration of treatment or would affect 
assessment of clinical status to a significant degree. 
3. Subject becomes pregnant. 
4. Subject refuses to continue treatment. 
5. Any reason the study physician deems it necessary for the benefit of the participant. 
6. Subject is lost to follow-up. 
6. Study Calendar 
 
Table 3. Calendar of study events/procedures. 
Parameter 
Pre-
Study 
Surgery 
(Day 0) 
Day1 
Day 2* 
Day 3* 
Day 7  
(±2 
days) 
Day 90 
(±14 
days) 
Post-Op 
 Years 2 
& 4 
(±14 
days) 
General Patient History 
Form 
X 
 
 
 
 
 
 
 
Update Medical History 
 
X 
X 
 
 
X 
X 
X 
Treatment administration 
(Ropivacaine/Placebo) 
 
X 
 
 
 
 
 
 
Intra-Operative Case report 
Form (CRF) 
 
X 
 
 
 
 
 
 
Adverse Events of 
Interest/SAE Assessment 
 
X 
X 
X 
X 
X 
X 
 
Pain Meds/Opioid Use 
X 
 
X 
X 
X 
X 
X 
 
Questionnaires 
 
 
 
 
 
 
 
 
Patient Pain Assessment 
Questionnaire 
X 
 
X 
X 
X 
X 
X 
X 


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Subjective Pain Survey 
X 
 
 
 
 
 
 
 
BREAST-Q©, Pre-Op 
X 
 
 
 
 
 
 
 
BREAST-Q©, Post-Op 
 
 
 
 
 
 
X 
X 
RAND-36 Questionnaire 
X 
 
 
 
 
X 
X 
X 
Quick DASH 
Questionnaire 
X 
 
 
 
 
X 
X 
X 
Note: Additional tests may be performed at the discretion of the treating investigator as clinically 
indicated. 
* A study team member will call discharged patients on Day 2 and Day 3 to collect data.  Phone calls will 
not occur on weekends but will resume the following Monday. If the patient is not discharged, study 
follow-up will occur at bedside. 
 
7.  Pharmaceutical Information 
7.1 
Ropivacaine (Naropin) 
7.1.1 Product Identification 
Naropin® injection contains ropivacaine HCl, which is a member of the amino amide class of 
local anesthetics. Naropin® (ropivacaine HCl) injection is a sterile, isotonic solution that 
contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for 
injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is 
administered parenterally. 
Ropivacaine HCl is chemically described as S-(-)-1-propyl-2',6'-pipecoloxylidide hydrochloride 
monohydrate. The drug substance is a white crystalline powder, with a molecular formula of 
C17H26N2O•HCl•H2O, molecular weight of 328.89 and the following structural formula: 
 
 
At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n-
octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The 
pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of 
mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared 
to bupivacaine and mepivacaine. 


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Naropin (ropivacaine hcl) Injection is preservative-free and is available in single dose containers 
in 2 (0.2%), 5 (0.5%), 7.5 (0.75%) and 10 mg/mL (1%) concentrations. The specific gravity of 
Naropin (ropivacaine hcl) Injection solutions range from 1.002 to 1.005 at 25°C.  
 
7.1.2 Mode of Action 
A) MECHANISM OF ACTION 
1) Local anesthetics bind to the internal axoplasmic membrane (presumably a 
phospholipid receptor) to reduce ion flux, especially the sodium channel, resulting in 
inhibition of depolarization and subsequent nerve conduction blockade. Ropivacaine may 
have a greater propensity for blocking small myelinated A fibers and nonmyelinated C 
fibers (pain fibers) than bupivacaine; sensory blockade with ropivacaine is generally 
more pronounced than motor blockade, and the intensity and duration of motor block is 
lower and shorter with ropivacaine than with equal doses of bupivacaine. 
a) With single injections of high concentrations of ropivacaine for epidural analgesia, 
motor blockade was dose-dependent in segments close to the injection site (L2/3); in 
abdominal muscles, the blockade was partial and not clearly correlated with ropivacaine 
concentration. 
 b) For epidural analgesia, ropivacaine infused continuously at a 0.1% concentration 
produced motor blockage so slight that all study subjects could be mobilized; at 0.2% and 
0.3% concentrations of ropivacaine infusion, blockade was moderate (40% to 50% of 
baseline force was present). 
B) PHARMACOLOGY 
1) Ropivacaine is a long-acting amino-amide local anesthetic with pharmacodynamic 
properties and uses similar to those of bupivacaine. The S-(-)-enantiomer of 1-propyl-2,6-
pipecoloxylidide, ropivacaine is structurally similar to bupivacaine and mepivacaine. The 
S-(-) and R-(+) enantiomers of ropivacaine are equipotent in terms of local anesthetic 
effects; however, nerve block with the S-(-) isomer is slightly longer, and toxicity appears 
to be less. In contrast to ropivacaine, both bupivacaine and mepivacaine are available as 
racemic mixtures. 
2) Bupivacaine is considered more cardiotoxic than other amide-type local anesthetics, 
and this is attributed to its R-(-) isomer. Ropivacaine was developed to be a less toxic 
alternative to bupivacaine. In addition to its availability in the S-isomeric form, 
ropivacaine differs from bupivacaine by substitution of the butyl group by a propyl 
group; these changes make ropivacaine less lipid soluble and potentially less likely to 
induce cardiotoxic effects. 
3) In vitro and in vivo studies have suggested a similar anesthetic profile with 
bupivacaine and ropivacaine, but a greater potential for central nervous system toxicity 
and cardiotoxicity with the former when given in equal doses (milligram-basis); 


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ropivacaine may have a greater margin of safety between convulsive and lethal doses. 
Ropivacaine was less likely than bupivacaine to produce mild cardiovascular and central 
nervous system changes after intravenous infusion in one study involving healthy 
subjects. The intensity and duration of motor blockade have tended to be less with 
epidural ropivacaine compared to epidural bupivacaine. 
4) Ropivacaine has vasoconstrictor properties. The drug has produced significant 
blanching and reduced cutaneous blood flow when infiltrated. The addition of 
epinephrine may not measurably decrease drug absorption or prolong the duration of 
blockade of ropivacaine. 
7.1.3 Storage and Stability 
Store solutions at 15-30°C. 
Do not freeze. Due to the nature of the Polyamp® and the Polybag® systems, the containers 
must not be re-autoclaved. 
NAROPIN (ropivacaine hydrochloride) solutions are sterile, without preservative and are for 
single use only. Discard unused portion. 
7.1.4 Indications 
NAROPIN (ropivacaine hydrochloride) is indicated for: 
Analgesia 
Acute pain management in connection with: 
• Continuous epidural infusion or intermittent bolus administration e.g., 
postoperative or labour pain; 
• Field block e.g. infiltration.  
Anaesthesia 
Surgical anaesthesia in connection with:  
• Epidural block for surgery, including Caesarean section;  
• Major nerve block e.g., brachial plexus block;  
• Field block e.g., infiltration. 
 
7.1.5 Contraindications 
NAROPIN (ropivacaine hydrochloride) is contraindicated: 
• 
In patients with a hypersensitivity to ropivacaine or any other local anaesthetic 
agent of the amide type; 
• 
For intravenous regional anaesthesia (Bier block); 
• 
In obstetric paracervical block anaesthesia. Use of other local anaesthetics in 
this technique has resulted in foetal bradycardia and death. 


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7.1.6 Availability 
Absorption: The systemic concentration of local anaesthetics is dependent upon the total dose 
and the concentration administered, the route of administration, the patient’s hemodynamic/ 
circulatory condition, and the vascularity of the injection site. Ropivacaine follows linear 
pharmacokinetics and the maximum plasma concentration is proportional to the dose. 
Ropivacaine shows complete and biphasic absorption from the epidural space. The mean half-
lives of the two phases are in the order of 14 min and 4 h. The slow absorption is the rate-
limiting factor in the elimination of ropivacaine, which explains why the apparent elimination 
half-life is longer after epidural than after intravenous administration. Ropivacaine shows dose 
proportionality at epidural doses up to 250 mg and intravenous doses up to 80 mg. 
Distribution: Following intravenous administration, the volume of distribution of NAROPIN is 
approximately 40 L. NAROPIN is extensively bound to alpha1-acid glycoprotein in plasma with 
an unbound, i.e. pharmacologically active, fraction of about 6%. An increase in total plasma 
concentration during continuous epidural infusion has been observed in postoperative patients 
and is related to the postoperative increase of alpha1-acid glycoprotein. Variations in unbound 
concentration have been much less than in total plasma concentration. 
Ropivacaine readily crosses the placenta and equilibrium, in regard to unbound concentration, is 
rapidly reached. The degree of plasma protein binding in the foetus is less than in the mother, 
which results in lower total plasma concentrations in the foetus than in the mother. The ratios of 
umbilical vein to maternal vein total and free concentrations are 0.31 and 0.74, respectively. 
Metabolism: Ropivacaine is extensively metabolized in the liver predominantly to 3- hydroxy-
ropivacaine by an aromatic hydroxylation process mediated by cytochrome P4501A2 and N-
dealkylation to PPX mediated by CYP3A4. Conjugated and unconjugated 3-hydroxy- 
ropivacaine represent the major urinary metabolites. Urinary excretion of 4-hydroxy ropivacaine, 
N-dealkylated pipecoloxylidide (S-PPX) and both the 3-hydroxy and 4-hydroxy N-dealkylated 
metabolites account for less than 3% of the dose. An additional metabolite, 2- hydroxy-methyl-
ropivacaine has been identified, but not quantified in urine. S-PPX and 3- hydroxy ropivacaine 
are the major metabolites excreted in the urine during epidural infusion. A total S-PPX 
concentration in the plasma was about half that of total ropivacaine however, mean unbound 
concentrations of S-PPX were about 7 – 9 times higher than that of unbound ropivacaine 
following continuous epidural infusion up to 72 hours. The threshold for CNS toxicity in rats due 
to unbound plasma concentrations of PPX is approximately 12 times higher than that of unbound 
ropivacaine. S-PPX, 3-hydroxy ropivacaine, and 4-hydroxy ropivacaine have a pharmacological 
activity in animal models less than that of ropivacaine. 
There is no evidence of in vivo racemization of ropivacaine. 
 
Excretion: After intravascular administration, 86% of the total dose of ropivacaine is excreted in 
the urine of which approximately 1% is the parent compound and 36% is 3- hydroxy- 
ropivacaine. Ropivacaine has a mean total plasma clearance in the order of 440 mL/min, an 
unbound plasma clearance of 8 L/min, a renal clearance of 1 mL/min, and a volume of 
distribution at steady state of 47 L. Ropivacaine has an intermediate hepatic extraction ratio of 


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about 0.4. The terminal elimination half-life is 1.6 to 1.8 hours after intravenous administration, 
4.1-6.5 hours after epidural administration, and 5.7-8.0 hours after brachial plexus block. The 
total and unbound clearance of epidural ropivacaine at term in pregnancy (223-256 mL/min and 
2.8-3.3 L/min, respectively), are lower than that observed in non-pregnant patients. 
 
 
 
7.1.7 Side Effects 
 
Reactions to NAROPIN (ropivacaine hydrochloride) are characteristic of those associated with 
other long-acting local anesthetics of the amide type. 
In clinical trials, the great majority of adverse events reported with ropivacaine were related to 
the expected effects of the block and to the clinical situation, rather than reactions to the drug. 
When all clinical studies were pooled (total n=3056), hypotension and nausea were registered in 
41.2% (n=1259) and 28.4% (n=867) of the patients, respectively. Similar incidences were 
reported for bupivacaine in the double-blind comparisons. 
Adverse reactions to local anesthetics are very rare in the absence of overdose or inadvertent 
intravascular injection. The effects of systemic overdose and unintentional intravascular 
injections can be serious, but should be distinguished from the physiological effects of the nerve 
block itself (e.g. a decrease in blood pressure, bradycardia, urinary retention after epidural and 
intrathecal block), and events caused directly by needle puncture (e.g. spinal haematoma, 
postdural puncture headache), or indirectly by introduction of micro-organisms (e.g. meningitis 
and epidural abscess). 
 
Acute systemic toxicity from local anaesthetics is generally dose-related and due to high plasma 
levels which may result from overdosage (see OVERDOSAGE), rapid absorption from the 
injection site, diminished tolerance, or from inadvertent intravascular injection. Most commonly, 
the acute adverse experiences originate from the central nervous and cardiovascular systems. 
 
7.1.8 Overdosage 
 
Systemic toxic reactions primarily involve the central nervous system and cardiovascular system. 
Such reactions are caused by high plasma levels encountered during therapeutic use, overdose, or 
to unintended intravascular or subarachnoid injection (see ADVERSE REACTIONS and 
WARNINGS AND PRECAUTIONS). CNS reactions are similar for all amide local anesthetics, 
while cardiac reactions are more dependent on the drug, both quantitatively and qualitatively. 
 
Symptoms 
Accidental intravascular injections may cause immediate (within seconds to a few minutes) toxic 
effects. In the event of overdose, peak plasma concentrations may not be reached for 1 to 2 
hours, depending on the site of injection, with signs of toxicity thus being delayed. 
Central nervous system toxicity is a graded response with symptoms and signs of escalating 
severity. First symptoms are usually light-headedness, circumoral paraesthesia, numbness of the 


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tongue, hyperacusis, tinnitus and visual disturbances. Dysarthria, muscular rigidity and muscular 
twitching are more serious and may precede the onset of generalized convulsions. These signs 
must not be mistaken for a neurotic behavior. Unconsciousness and grand mal convulsions may 
follow which may last from a few seconds to several minutes. Hypoxia and hypercarbia occur 
rapidly following convulsions due to the increased muscular activity, together with the 
interference with normal respiration and loss of the airway. In severe cases apnea may occur. 
Acidosis, hyperkalemia, hypocalcemia and hypoxia increase and extend the toxic effects of local 
anesthetics. 
 
Recovery is due to redistribution and metabolism of the local anesthetic drug. Recovery may be 
rapid unless large amounts of the drug have been administered. 
 
Cardiovascular system toxicity indicates a more severe situation and is generally preceded by 
signs of toxicity in the central nervous system, unless the patient is receiving a general anesthetic 
or is heavily sedated with drugs such as a benzodiazepine or barbiturate. Hypotension, 
bradycardia, arrhythmia and cardiac arrest may occur as a result of high systemic concentrations 
of local anesthetic. In volunteers, the intravenous infusion of ropivacaine resulted in signs of 
depression of conductivity and contractility. 
 
In children early signs of local anesthetic toxicity may be difficult to detect in cases where the 
block is given during general anesthesia. It should be noted that NAROPIN (ropivacaine 
hydrochloride) is not approved for use in pediatric patients. 
 
 
Treatment 
The first consideration is prevention, best accomplished by incremental injection of NAROPIN, 
careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s 
state of consciousness after each local anesthetic injection and during continuous infusion. At the 
first sign of change, oxygen should be administered. If signs of acute systemic toxicity appear, 
injection of the local anesthetic should be immediately stopped. 
 
The first step in the management of systemic toxic reactions, as well as hypoventilation or apnea 
due to unintentional subarachnoid injection of drug solution, consists of immediate attention to 
the establishment and maintenance of a patent airway and assisted or controlled ventilation with 
oxygen and a delivery system capable of permitting immediate positive airway pressure by mask 
and bag or tracheal intubation. This may prevent convulsions if they have not already occurred. 
 
If necessary, use drugs to control the convulsions. An anticonvulsant should be given i.v. if the 
convulsions do not stop spontaneously in 15-20 seconds. Thiopental 1–3 mg/kg i.v. will abort the 
convulsions rapidly. Alternatively, diazepam 0.1 mg/kg i.v. may be used, although its action will 
be slow. Both these drugs, however, depress the central nervous system, respiratory and cardiac 
functions, add to postictal depression, and may result in apnea. 
 
Prolonged convulsions may jeopardize the patient’s ventilation and oxygenation. If so, injection 
of a muscle relaxant such as succinylcholine (1 mg/kg) will stop the muscle convulsions rapidly, 


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so that ventilation and oxygenation can be controlled. Endo-tracheal intubation must be 
considered in such situations. 
If cardiovascular depression is evident (hypotension, bradycardia) administration of intravenous 
fluids or a vasopressor such as ephedrine or epinephrine may be required. 
 
Should circulatory arrest occur, immediate cardiopulmonary resuscitation should be instituted. 
Optimal oxygenation and ventilation and circulatory support as well as treatment of acidosis are 
of vital importance. 
 
Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the 
likelihood of a successful outcome. 
 
Clinical data from patients experiencing local anesthetic-induced convulsions demonstrated rapid 
development of hypoxia, hypercarbia, and acidosis within a minute of the onset of convulsions. 
These observations suggest that oxygen consumption and carbon dioxide production are greatly 
increased during local anesthetic convulsions and emphasize the importance of immediate and 
effective ventilation with oxygen, which may avoid cardiac arrest. 
 
In human volunteers given intravenous NAROPIN, the mean maximum tolerated total and free 
arterial plasma concentrations were 4.3 and 0.6 μg/mL respectively, at which time moderate 
CNS symptoms (muscle twitching) were noted. 
 
7.2 
Placebo 
Patients randomized to the placebo group will be administered 0.9% sodium chloride solution at 
a dose of 0.8 mL/kg, using the technique described in the treatment administration section 
(section 5.7). 


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7.3 
Opioid use 
 
 
Other opioid use such as IV 
PCA (morphine) and PO opioids 
(oxycodone) 
will 
be 
standardized by conversion into 
morphine equivalents based on a 
24-hour regimen using Table 4. 
 
 
Table 4. Standardization table for Opioid use by participants 
based on the “Equianalgesic Dosing of Opioids for Pain 
Management*.” 
Morphine (mg/day) 
Oxycodone (mg/day) 
Oral 
IV 
Oral 
IV 
45-134 
8-22 
22.5-67 
12-33 
135-224 
23-37 
67.5-112 
33.1-56 
225-314 
38-52 
112.5-157 
56.1-78 
315-404 
53-67 
157.5-202 
78.1-101 
405-494 
68-82 
202.5-247 
101.1-123 
495-584 
83-97 
247.5-292 
123.1-147 
585-674 
98-112 
292.5-337 
147.1-168 
675-764 
113-127 
337.5-382 
168.1-191 
765-854 
128-142 
382.5-427 
191.1-213 
855-944 
143-157 
427.5-472 
213.1-236 
945-1034 
158-172 
472.5-517 
236.1-258 
1035-1124 
173-187 
517.5-562 
258.1-281 
*http://pharmacy.uams.edu/formulary/narc_conv_chart.htm 


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8. Administrative Procedures 
8.1 Protocol Amendments 
Any changes to the protocol will be made in the form of an amendment and must be approved by 
the IRB prior to implementation.   
8.2 
Informed Consent 
The investigator or other qualified study team member will explain to each subject the nature of 
the study, its purpose, the procedures involved, the expected duration of study participation, the 
potential risks and benefits involved and any discomfort it may entail.  Each subject will be 
informed that participation in the study is voluntary and that he/she may withdraw from the study 
at any time and that withdrawal of consent will not affect his/her subsequent medical treatment 
or relationship with the treating physician or institution.  The informed consent will be given by 
means of a standard written statement, written in non-technical language, which will be IRB 
approved.  No subject will enter the study before his/her informed consent has been obtained. 
 
In accordance with the Health Information Portability and Accountability Act (HIPAA), the 
written informed consent document will include a subject authorization to release medical 
information to the study sponsor and supporting agencies and/or allow these bodies, a regulatory 
authority, or Institutional Review Board access to subjects’ medical information that includes all 
hospital records relevant to the study, including subjects’ medical history. 
8.3 Ethics and Good Clinical Practice 
This study will be carried out in compliance with the protocol and Good Clinical Practice, as 
described in the following: 
 
1. ICH Harmonized Tripartite Guidelines for Good Clinical Practice 1996. 
2. US 21 Code of Federal Regulations dealing with clinical studies (including parts 50 and 
56 concerning informed consent and IRB regulations). 
3. Declaration of Helsinki, concerning medical research in humans (Recommendations 
Guiding Physicians in Biomedical Research Involving Human Subjects, Helsinki 1964, 
amended Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996). 
 
The investigator agrees to adhere to the instructions and procedures described herein and, 
thereby, to adhere to the principles of Good Clinical Practice to which it conforms. 
 
9. Adverse Events 
9.1 General 
This study is collecting data regarding post-operative pain after a planned surgical procedure.  
The placement of the paravertebral block and ropivacaine is not expected to cause increased side 
effects or problems than those already anticipated with surgery.  Subjects randomized to the 
placebo group will be at increased risk of harm related to the subcutaneous paravertebral saline 
injections without the chance of benefit. Any events that occur that are deemed “unexpected” to 


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the surgical procedure(s) performed, but related to the study procedures will be reported per 
current institutional requirements. 
9.2 
Definitions 
9.2.1 Adverse Event (AE)   
Any undesirable sign, symptom or medical condition occurring after starting study drug (even if 
the event is not considered to be related to the study) is considered an adverse event.  An 
undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., 
tachycardia, enlarged liver), or the abnormal results of an investigation (e.g., laboratory findings, 
electrocardiogram). 
  
Medical conditions/diseases present before starting study treatment are only considered adverse 
events if they worsen after starting study treatment (any procedures specified in the protocol).  
Adverse events occurring before starting study treatment but after signing the informed consent 
form will be recorded.  Abnormal laboratory values or test results constitute adverse events only 
if they induce clinical signs or symptoms or require therapy. 
9.2.2 Serious Adverse Event or Reaction   
A serious adverse event is an undesirable sign, symptom or medical condition which: 
 
• Is fatal or life-threatening; 
• Required or prolonged hospitalization; 
• Results in persistent or significant disability/incapacity; 
• Constitutes a congenital anomaly or a birth defect; 
• Is medically significant, may jeopardize the subject and may require medical 
or surgical intervention to prevent one of the outcomes listed above. 
 
Events not considered to be serious adverse events are hospitalizations for: 
 
• Routine treatment or monitoring of the studied indication not associated with 
any deterioration in condition, or for elective procedures (i.e., venous access 
placement, etc.).  
• Treatment, which was elective or pre-planned, for a pre-existing condition that 
did not worsen. 
• Treatment on an emergency, outpatient basis for an event not fulfilling any of 
the definitions of serious given above and not resulting in hospital admission. 
 
The definition of serious adverse event (experience) also includes important medical event.  
Medical and scientific judgment should be exercised in deciding whether expedited reporting is 
appropriate in other situations, such as important medical events that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may require 
intervention to prevent one of the other outcomes listed in the definition above.  These should 
also usually be considered serious.  Examples of such events are intensive treatment in an 
emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do 
not result in hospitalization; or development of drug dependency or drug abuse. 


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9.2.3 Expectedness 
9.2.3.1 Unexpected adverse event:  An adverse event, which varies in nature, intensity or 
frequency from information on the investigational drug/agent provided in the 
Investigator’s Brochure, package insert or safety reports.  Any adverse event that is not 
included in the informed consent is considered “unexpected”. 
9.2.3.2 Expected (known) adverse event:  An adverse event, which has been reported in the 
Investigator’s Brochure.  An adverse event is considered “expected”, only if it is 
included in the informed consent document as a risk. 
9.3 
Relationship 
The relationship of all adverse events and serious adverse events to study medication will be 
assessed by an investigator and assigned as follows: 
9.3.1 Definitely:  An adverse event which has a timely relationship to the administration of the 
investigational drug/agent, follows a known pattern of response, and for which no 
alternative cause is present.  
9.3.2 Probably:  An adverse event which has a timely relationship to the administration of the 
investigational drug/agent, follows a known pattern of response, but for which a potential 
alternative cause may be present.  
9.3.3 Possibly:  An adverse event which has a timely relationship to the administration of the 
investigational drug/agent, follows no known pattern of response, but a potential 
alternative cause does not exist. 
9.3.4 Unlikely:  An adverse event which does not have a timely relationship to the 
administration of the investigational drug/agent, follows no known pattern of response, 
does not reappear or worsen after re-administration of the investigational drug/agent (if 
applicable), and for which there is evidence that it is related to a cause other than the 
investigational drug/agent. 
9.3.5 Unrelated:  An adverse event for which there is evidence that it is definitely related to a 
cause other than the investigational drug/agent.  In general, there is no timely relationship 
to the administration of the investigational drug/agent, or if there is a timely relationship, 
the event does not follow a known pattern of response, and there is an alternative cause.  
9.4 
Reporting Procedures 
9.4.1 General 
All adverse events will be captured on the appropriate study-specific case report forms (CRFs).  
In addition, all serious adverse events, regardless of causality to study drug, will be reported 
promptly to the Principal Investigator and Study Coordinator. 


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9.4.2 Institutional Review Board 
All adverse events and serious adverse events will be reported to the IRB per current institutional 
standards.  If an adverse event requires modification of the study protocol and informed consent, 
these modifications will be provided to the IRB with the report of the adverse event or as soon as 
possible thereafter. 
9.4.3 Food and Drug Administration (FDA) 
In this trial using a medication for an FDA-approved indication, unexpected adverse events 
believed to be definitely, probably, or possibly related to the medication (s) will be reported to 
the Food and Drug Administration via Med Watch (using the online form available at 
https://www.accessdata.fda.gov/scripts/medwatch/; by telephone 1-800-FDA-1088; or by fax 1-
800-FDA-0178 using form available at http://www.fda.gov/medwatch/report/hcp.htm).  This 
reporting mechanism will be used to report events that may be related to the use of the 
ropivacaine. 
9.5 Data and Safety Monitoring 
This is a DSMP Level I study under the SKCCC Data Safety Monitoring Plan. The Clinical 
Research Office QA Group will perform an audit at the end of the first year and then periodically 
depending on the rate of accrual and prior audit results. The SKCCC Safety Monitoring 
Committee will review all trial monitoring and reporting annually. The PI will be responsible for 
monitoring the study. The study’s data will be continuously reviewed to assure its validity. The 
PI will constantly review the safety reports to confirm that the safety outcomes favor 
continuation of the study. Additionally, the PI will be responsible for maintaining the clinical 
protocol, monitoring clinical trial efficacy endpoints, reporting adverse events, assuring that 
consent is obtained and documented, reporting of unexpected outcomes, and reporting the status 
of the trial in the continuing renewal report submitted to the IRB and to the trial monitoring 
review group.  
 
Content of the continuing renewal report at a minimum will include year-to-date and full trial 
data on: accrual and eligibility, protocol compliance, treatment administration, toxicity and ADR 
reports, response, survival, regulatory compliance and compliance with prearranged statistical 
goals. The report will be submitted in a timely manner according to the schedule defined by 
Johns Hopkins Medicine Institutional Review Board. 
9.6 Data Management 
All information will be collected on study-specific case report forms (CRFs) by study staff.  The 
Principal Investigator as well as the Sidney Kimmel Comprehensive Cancer Center Clinical 
Research Office will review these data for completeness and accuracy.  
9.7 Safety Meetings 
Scheduled meetings will take place as needed and will include the protocol principal 
investigator, study coordinator(s), sub-investigators (as appropriate), and biostatisticians (as 
appropriate) involved with the conduct of the protocol.  During these meetings matters related to 
the following will be discussed: safety of protocol participants, validity and integrity of the data, 
enrollment rate relative to expectation, characteristics of participants, retention of participants, 


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adherence to the protocol (i.e., potential or real protocol deviations/violations), completeness of 
data collection, and progress of data analysis. 
9.8 Monitoring 
The principal investigator will have sole responsibility for monitoring and oversight of 
problems/events related to this research. 
10. Statistical Considerations 
This study is a randomized controlled trial based on the bilateral mastectomy followed by 
bilateral immediate tissue expander breast reconstruction surgical protocol currently in use at 
Johns Hopkins.  
 
Patients will be randomized 1:1 to either 0.5% ropivacaine pre-operatively placed paravertebral 
blocks or subcutaneous paravertebral saline (placebo) injections. Using two pain scales, the 
Patient Pain Assessment Questionnaire (Appendix A) and Subjective Pain Survey (Appendix B), 
the post-operative pain will be compared between treatment and control groups. Differences in 
opioids use between groups at different time points will also be assessed as a more objective 
measure of post-operative pain.  
 
10.1 Objectives 
10.1.1 Primary Objective 
To determine if post-operative static pain scores differ between women undergoing bilateral 
mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to 
ropivacaine- (treatment) pre-operatively placed paravertebral blocks or subcutaneous 
paravertebral saline (placebo) injections. 
 
Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of 
surgery while the patient is still hospitalized (post-operative day 0). This will be patient-provided 
data. Unblinded data analysis will compare scores between treatment and control groups.  
 
10.1.2 Secondary Objectives 
To determine if post-operative moving pain scores, opioids use, nausea, and sleep interference 
differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue 
expander reconstruction randomized either to ropivacaine- (treatment) pre-operatively placed 
paravertebral blocks or subcutaneous paravertebral saline (placebo) injections.   
 
Pain score, opioids use, nausea, and sleep interference data will be collected via patient self-
report. When possible (i.e., while hospitalized) objective data on opioids and other pain 
medication administered to the patient will be used. 
 


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10.1.3 Tertiary Objectives 
To determine if long-term changes in Quality of Life scores [the RAND-36 Health Survey, 
Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores] 
differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue 
expander reconstruction randomized either to ropivacaine- (treatment) pre-operatively placed 
paravertebral blocks or subcutaneous paravertebral saline (placebo) injections. 
 
This data will be collected via validated questionnaires through patient interviews at 3-months, 
2-years, and 4-years (±14 days) after surgery.  
 
Once enrolled in the study, participants will be encouraged to remain in the study for the 4 years 
following surgery in order to get final pain scores and quality-of-life/health outcome survey 
information.  Participants who cannot be contacted after several phone attempts and the sending 
of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year outcome 
assessments will be considered lost to follow-up.   
 
10.2 Study Design 
Descriptive statistics for all outcome data (primary, secondary, and tertiary) will be calculated 
for each treatment group (ropivacaine or placebo), for each time point (days 1-3, day 90, year 2 
and year 4). Student’s t-test or Wilcoxon rank sum test will be used to compare the 2 treatment 
groups with regards to continuous or ordinal (approximately continuous) data, based on the 
distribution of the values (normally distributed or not normally distributed).  Also change from 
baseline to each time point (follow-up) will be calculated for each outcome.  The distributions of 
these “change values” will be analyzed in the same manner (depending on distribution).  P-
values less than 0.05 will be considered statistically significant for the primary outcome.   
 
Longitudinal methods will be used to examine trends in scores, and changes in scores over time. 
 
Opioid use also will be analyzed. IV morphine delivered via a Patient Controlled Analgesia 
pump during the first 24 hours of post-operative hospitalization will be recorded. Oxycodone and 
Tylenol taken by the patient after the first 24 hours until post-operative day seven will be 
recorded by the patient unless the patient is still hospitalized, in which case it will be recorded in 
the patient’s medical record and abstracted by study staff.  Answers to pain questionnaires and 
information regarding analgesic use will be verified by daily telephone calls to the patients by 
study staff. A common “pain unit” will be developed to standardize the various methods of 
opioid administration.  Survival analyses will be used to compare time to opioid use, and time to 
stopping of opioid use.  Descriptive statistics will be used to quantify amount and timing of 
opioid use, as well as proportion of patients requiring opioids post-operatively. 
 
Furthermore, we will use the DASH survey, BREAST-Q©, and the RAND-36 to determine the 
amount of functional long-term differences (3 months, 2 and 4 years after surgery) between 
treatment groups.  These surveys will be used to compare the functional use of the arm before 
surgery to its use three months after mastectomy with immediate reconstruction.      
 


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Adverse events will be quantified and proportions of patients in each treatment group with 
different specific types of adverse events will be compared for safety data.  Chi Square tests or 
Fisher’s Exact Tests will be used to compare the proportions of patients with adverse events. 
 
10.3 Sample Size and Accrual 
We expect that it will take 24 months to collect data on all patients through Day 90. Assuming a 
placebo effect of 30%, we would anticipate a true difference of 1.5 VAS units between the two 
groups.  A true difference between scores of 4.1 to 2.6 would be clinically significant since it 
would bring a patient from the “moderate” down into the “mild” pain category. Thus a total of 70 
patients will enter this placebo-control parallel-design study. The probability is 90 percent that 
the study will detect a treatment difference at a two-sided 0.05 significance level. This is based 
on the assumption that the standard deviation of the response variable is 2.5. 
 
10.4 Interim Analyses for Efficacy.  
A total of two interim analyses for efficacy will occur after the enrollment of 28 (40%) and 42 
(60%) patients, giving a total of 3 ‘looks’ at the data including the final analysis at 70 patients 
enrolled. Because of the small sample size in the first and second interim analyses, we will test 
for the equality of static pain scores at 6 hours post-surgery by treatment group using the 
Wilcoxon rank sum test. This statistical test considers the rank of the pain scores without regard 
to the distribution of these outcome measures; however, the test of significance uses a Z-score, 
which has a standard normal distribution.  
 
In order to control for the overall type I error for the three proposed analyses, we will use a group 
sequential approached that utilizes the O'Brien-Fleming (1979)27 alpha spending function. The 
critical Z-values for the Wilcoxon rank sum test assuming O’Brien-Fleming boundaries were 
determined by the STATA command ‘landemets’, which calculates these boundaries following 
the method of Lan and DeMets (1983)28. Table X below gives the critical Z values and 
corresponding alpha levels at each analysis required to reject the null hypotheses of equality of 
pain scores by treatment group. In this null hypothesis, we consider a two-sided test which 
makes no assumption about the direction of the effect (e.g. placebo patients could potentially 
have a lower mean pain score than those on the intervention).   
 
Table 5: Critical Z values and corresponding alpha levels for test the null hypothesis that 
static 6 hour post-surgery pain scores are equal among treatment groups.  
Analysis 
number  
Proportion 
of total N  
critical |Z| 
to reject 
H0 
Alpha(i) 
level 
 
1 
0.4 
3.36 
0.00079 
2 
0.6 
2.68 
0.0076 
3 
1.0 
1.98 
0.05 
 


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References 
 
1. 
Al-Ghazal SK, Sully L, Fallowfield L, Blamey RW. The psychological impact of 
immediate rather than delayed breast reconstruction. Eur J Surg Oncol 2000;26:17-9. 
2. 
Cocquyt VF, Blondeel PN, Depypere HT, et al. Better cosmetic results and comparable 
quality of life after skin-sparing mastectomy and immediate autologous breast 
reconstruction compared to breast conservative treatment. Br J Plast Surg 2003;56:462-70. 
3. 
Khoo A, Kroll SS, Reece GP, et al. A comparison of resource costs of immediate and 
delayed breast reconstruction. Plast Reconstr Surg 1998;101:964-8; discussion 9-70. 
4. 
Alderman AK, McMahon L, Jr., Wilkins EG. The national utilization of immediate and 
early delayed breast reconstruction and the effect of sociodemographic factors. Plast 
Reconstr Surg 2003;111:695-703; discussion 4-5. 
5. 
Rosson GD, Singh NK, Ahuja N, Jacobs LK, Chang DC. Multilevel analysis of the impact 
of community vs patient factors on access to immediate breast reconstruction following 
mastectomy in Maryland. Arch Surg 2008;143:1076-81; discusion 81. 
6. 
Wilkins EG, Cederna PS, Lowery JC, et al. Prospective analysis of psychosocial outcomes 
in breast reconstruction: one-year postoperative results from the Michigan Breast 
Reconstruction Outcome Study. Plast Reconstr Surg 2000;106:1014-25; discussion 26-7. 
7. 
Legeby M, Segerdahl M, Sandelin K, Wickman M, Ostman K, Olofsson C. Immediate 
reconstruction in breast cancer surgery requires intensive post-operative pain treatment but 
the effects of axillary dissection may be more predictive of chronic pain. Breast 
2002;11:156-62. 
8. 
Legeby M, Sandelin K, Wickman M, Olofsson C. Analgesic efficacy of diclofenac in 
combination with morphine and paracetamol after mastectomy and immediate breast 
reconstruction. Acta Anaesthesiol Scand 2005;49:1360-6. 
9. 
Naja Z, Al Tannir M, Naccache N, El Rajab M, Al Sayyid K, Ziade F, Chatila M. General 
anaesthesia combined with bilateral paravertebral blockade (T11-T12-L1) vs general 
anaesthesia for bilateral varicocelectomy. A randomized double-blind clinical trial. J Med 
Liban. 2011 Jul-Sep;59(3):126-30. 
10. Kaya FN, Turker G, Basagan-Mogol E, Goren S, Bayram S, Gebitekin C. Preoperative 
multiple-injection thoracic paravertebral blocks reduce postoperative pain and analgesic 
requirements after video-assisted thoracic surgery. JCardiothorac Vasc Anesth. 2006 
Oct;20(5):639-43. Epub 2006 Aug 8. 
11. Moussa AA. Opioid saving strategy: bilateral single-site thoracic paravertebral block in 
right lobe donor hepatectomy. Middle East J Anesthesiol. 2008 Feb;19(4):789-801. 
12. Chelly JE, Ploskanych T, Dai F, Nelson JB. Multimodal analgesic approach incorporating 
paravertebral blocks for open radical retropubic prostatectomy: a randomized double-blind 
placebo-controlled study. Can J Anaesth. 2011 Apr;58(4):371-8. Epub 2010 Dec 21. 
13.  Fibla JJ, Molins L, Mier JM, Sierra A, Carranza D, Vidal G. The efficacy of paravertebral 
block using a catheter technique for postoperative analgesia in thoracoscopic surgery: a 
randomized trial. Eur J Cardiothorac Surg. 2011 Oct;40(4):907-11. Epub 2011 Feb 11. 
14. Splinter WM, Thomson ME. Somatic paravertebral block decreases opioid requirements in 
children undergoing appendectomy. Can J Anaesth. 2010 Mar;57(3):206-10. Epub 2010 
Jan 9. 


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15. Kaya FN, Turker G, Mogol EB, Bayraktar S. Thoracic paravertebral block for video-
assisted thoracoscopic surgery: single injection versus multiple injections.J Cardiothorac 
Vasc Anesth. 2012 Feb;26(1):90-4. Epub 2011 Nov 4. 
16. Tug R, Ozcengiz D, Güneş Y. Single level paravertebral versus caudal block in paediatric 
inguinal surgery.Anaesth Intensive Care. 2011 Sep;39(5):909-13. 
17.  Naja ZM, El-Rajab M, Ziade F, Al-Tannir M, Itani T. Preoperative vs. postoperative 
bilateral paravertebral blocks for laparoscopic cholecystectomy: a prospective randomized 
clinical trial.Pain Pract. 2011 Nov-Dec;11(6):509-15. doi: 10.1111/j.1533-
2500.2011.00447.x. Epub 2011 Mar 30. 
18.  Naja MZ, Ziade MF, Lönnqvist PA. General anaesthesia combined with bilateral 
paravertebral blockade (T5-6) vs. general anaesthesia for laparoscopic cholecystectomy: a 
prospective, randomized clinical trial.Eur J Anaesthesiol. 2004 Jun;21(6):489-95. 
19. Buckenmaier CC 3rd, Kwon KH, Howard RS, McKnight GM, Shriver CD, Fritz WT, 
Garguilo GA, Joltes KH, Stojadinovic A. Double-blinded, placebo-controlled, prospective 
randomized trial evaluating the efficacy of paravertebral block with and without continuous 
paravertebral block analgesia in outpatient breast cancer surgery. Pain Med. 2010 
May;11(5):790-9. 
20. Moller JF, Nikolajsen L, Rodt SA, Ronning H, Carlsson PS. Thoracic paravertebral block 
for breast cancer surgery: a randomized double-blind study. Anesth Analg. 2007 
Dec;105(6):1848-51, table of contents. 
21. Pusch F, Freitag H, Weinstabl C, Obwegeser R, Huber E, Wildling E. Single-injection 
paravertebral block compared to general anaesthesia in breast surgery. Acta Anaesthesiol 
Scand. 1999 Aug;43(7):770-4. 
22. Aufforth R, Jain J, Morreale J, Baumgarten R, Falk J, Wesen C. Paravertebral blocks in 
breast cancer surgery: is there a difference in postoperative pain, nausea, and vomiting? 
Ann Surg Oncol. 2012 Feb;19(2):548-52. Epub 2011 Jul 16. 
23. Kitowski NJ, Landercasper J, Gundrum JD, De Maiffe BM, Chestnut DH, Bottcher ML, 
Johnson JM, Johnson RL. Local and paravertebral block anesthesia for outpatient elective 
breast cancer surgery. Arch Surg. 2010 Jun;145(6):592-4. 
24. Coopey SB, Specht MC, Warren L, Smith BL, Winograd JM, Fleischmann K. Use of 
Preoperative Paravertebral Block Decreases Length of Stay in Patients Undergoing 
Mastectomy Plus Immediate Reconstruction. Ann Surg Oncol 2012; DOI 10.1245/s10434-
012-2678-7. Epub ahead of print 
 
25. Pu LL. The use of a pain pump for optimal postoperative pain management. Plast Reconstr 
Surg 2006;117:2066-9. 
26. Naja MZ, Lonnqvist PA. Somatic paravertebral nerve blockade: incidence of failed block 
and complications. Anaesthesia. 2001; 56: 1184-8. 
27. O’Brien, P.C. and Fleming. T.R. (1979). “A Multiple Testing Procedure for Clinical 
Trials.” Biometrics, 35: 549-556.  
28. Lan K. and DeMets D.L. (1983). “Discrete sequential boundaries for clinical trials.” 
Biometrika, 70: 659-663. 
 


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APPENDICES 
 
A 
Patient Pain Assessment Questionnaire 
B 
Subjective Pain Survey 
C 
BREAST-Q© (Pre-Operative) 
D 
BREAST-Q© (Post-Operative) 
E 
RAND-36 Questionnaire 
F 
Quick DASH Questionnaire 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix A:  Patient Pain Assessment Questionnaire 
 
Subject Number: ____________ Study Personnel: _________________________________  
 
Last Name: __________________________First Name: _____________________________    
 
MRN: ________________ DOB: ______________ Date: ___/___/_____ Time: ___________ 
 
 
    Thank you for participating in this study. Please answer the following questions. 
 
 
1. On the diagram, please place an X on the area(s) that hurt the most.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
        Right                                                        Left             Left                                                   Right  
                                           FRONT                                                                       BACK  
 
2. Please rate your pain by filling in on the scale below the number that best describes your pain at its 
worst in the last 24 hours. 
 
 
No Pain                                                                                                                          Worst Possible 
Pain 


       0             1             2             3             4             5             6             7             8              9             10 

 
 
 
 
 
 
3. Please rate your pain by filling in on the scale below the number that best describes your pain at its 
least in the last 24 hours. 


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No Pain                                                                                                                          Worst Possible 
Pain 


       0             1             2             3             4             5             6             7             8              9             10

 
 
 
4. Please rate your pain by filling in on the scale below the number that best describes your pain on 
the average in the last 24 hours. 
 
 
No Pain                                                                                                                          Worst Possible 
Pain 


       0             1             2             3             4             5             6             7             8              9             10
 
 
 
5. Please rate your pain by filling in on the scale below the number that best describes your pain right 
now. 
 
 
No Pain                                                                                                                          Worst Possible 
Pain 

       0             1             2             3             4             5             6             7             8              9             10
 
 
 
6. In the past 24 hours, how much relief have pain treatments or medications provided? Please darken 
the circle that most shows how much relief you have received. 
 
 
No Relief                                                                                                                                 Complete 
Relief 
      
        0             1             2             3             4             5             6             7             8              9             10 
 
 
     
 7. In the past 24 hours, how many times did you experience nausea? 
 
None       One         Two       Three       Four         Five         Six       Seven      Eight        Nine + 

  
    0             1             2             3             4               5               6             7             8              9        
 
 
 


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      8. In the past 24 hours, how many times did you experience vomiting? 
 
None       One         Two       Three       Four         Five         Six       Seven      Eight        Nine + 

      
    0             1             2             3             4               5               6             7             8              9        
 
 
Please darken the number in the box that best describes the extent your pain has interfered with 
your daily activities.  If you are unsure how to answer a question, choose the answer that comes 
closest to how you feel.  
 
            9. Static Pain 
 
 
                          No Interference                                                                                    Complete 
Interference

a. Lying in Bed0        1        2        3         4        5         6         7         8        9        10


b. Sitting up in Bed0        1        2        3         4        5         6         7         8        9        10

 
c. Laughing0        1        2        3         4        5         6         7         8        9        10

 
d. Coughing0        1        2        3         4        5         6         7         8        9        10

 
e. Sneezing0        1        2        3         4        5         6         7         8        9        10

 
f. Talking0        1        2        3         4        5         6         7         8        9        10

 
g. Singing0        1        2        3         4        5         6         7         8        9        10

 
h. Watching TV 0        1        2        3         4        5         6         7         8        9        10
 
 
            
 
 
 
 
 
 
 
 
 
 
 
 
10. Moving Pain 
 


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                          No Interference                                                                                    Complete 
Interference

a. Getting out of Bed0        1        2        3         4        5         6         7         8        9        10
 
 
b. Bending0        1        2        3         4        5         6         7         8        9        10
 
 
c. Bathing Yourself 0        1        2        3         4        5         6         7         8        9        10
 
 
d. Dressing Yourself 0        1        2        3         4        5         6         7         8        9        10
 
 
e. Lifting 0        1        2        3         4        5         6         7         8        9        10
 
 
f. Carrying Groceries0        1        2        3         4        5         6         7         8        9        10

 
g. Climbing Stairs 0        1        2        3         4        5         6         7         8        9        10

 
h. Stretching 0        1        2        3         4        5         6         7         8        9        10
 
 
   11.  Please darken one number that describes how, during the past 24 hours, pain has interfered    
   with  your: 
 
A. General Activity 
 
 
Does not interfere                                                                                                     Completely 
Interferes

     0             1             2             3             4             5             6             7             8              9             10 

 
 
B. Mood 
 
 
Does not interfere                                                                                                     Completely 
Interferes

     0             1             2             3             4             5             6             7             8              9             10 

 
 
 
 
 
 
 
C. Relations with other people 
        


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 38 
 
Does not interfere                                                                                                     Completely 
Interferes

     0             1             2             3             4             5             6             7             8              9             10 

 
 
D. Sleep 
    
 
Does not interfere                                                                                                     Completely 
Interferes

     0             1             2             3             4             5             6             7             8              9             10 
 
 
E. Enjoyment of Life 
 
 
Does not interfere                                                                                                     Completely 
Interferes

    0             1             2             3             4             5             6             7             8              9             10 
 
 
F. Ability to Concentrate 
        
 
Does not interfere                                                                                                     Completely 
Interferes

     0             1             2             3             4             5             6             7             8              9             10 

 
 
G. Appetite      
 
Does not interfere                                                                                                     Completely 
Interferes

     0             1             2             3             4             5             6             7             8              9             10 

 
 
H. Overall Quality of Life 
 
Does not interfere                                                                                                     Completely 
Interferes

     0             1             2             3             4             5             6             7             8              9             10 

 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 39 
Appendix B:  Subjective Pain Survey 
 
Subject Number: ____________ Study Personnel: _________________________________  
 
Last Name: __________________________First Name: _____________________________    
 
MRN: ________________ DOB: ______________ Date: ___/___/_____ Time: ___________  
 
Thank you for participating in this study. After reading each question, please circle the number in 
the box that best describes your situation.  If you are unsure how to answer a question, choose the 
answer that comes closest to how you feel.  Please answer all questions. 
 
               On a scale of 1 to 5, please indicate how painful you believe these scenarios are: 
 
 
Not painful 
at all 
A little 
painful 
Somewhat 
painful 
Quite 
painful 
Extremel
y painful 
 
 
a. Biting one’s tongue?   
 
1 
2 
3 
4 
5 
 
b. An average toothache?      
 
1 
2 
3 
4 
5 
 
c. Burning one’s hand on a stove?    
        
1 
2 
3 
4 
5 
 
d. Badly spraining one’s ankle? 
 
1 
2 
3 
4 
5 
 
e. Average migraine headache?    
 
1 
2 
3 
4 
5 
 
f. Receiving an intramuscular 
injection? 
 
1 
2 
3 
4 
5 
  
g. Stubbing one’s toe really hard? 
 
1 
2 
3 
4 
5 
 
h. The initial pain from a bee sting?  
1 
2 
3 
4 
5 
 





 





 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 40 
Appendix C: BREAST-Q© Reconstruction Module  
Preoperative Questionnaire 
 
Subject Number: ____________ Study Personnel: _________________________________  
 
Last Name: __________________________First Name: _____________________________    
 
MRN: ________________ DOB: ______________ Date: ___/___/_____ Time: ___________ 
 
After reading each question, please circle the number in the box that best describes your 
situation.  If you are unsure how to answer a question, choose the answer that comes closest to 
how you feel.  Please answer all questions. 
 
1. With your breasts in mind, or if you have had a mastectomy, with your breast area in mind, in the 
past 2 weeks, how satisfied or dissatisfied have you been with: 
 
 
Very 
Dissatisfie
d 
Somewhat 
Dissatisfie
d 
Somewhat 
Satisfied 
Very  
Satisfied 
a. 
How you look in the mirror clothed? 
1 
2 
3 
4 
b. 
How comfortably your bras fit? 
1 
2 
3 
4 
c. 
Being able to wear clothing that is more 
fitted? 
1 
2 
3 
4 
d. 
How you look in the mirror unclothed? 
1 
2 
3 
4 
 
 
2. With your breasts in mind, or if you have had a mastectomy, with your breast area in mind, in the 
past 2 weeks, how often have you felt: 
 
 
None of 
the time 
A little of 
the time 
Some of 
the time 
Most of 
the time 
All of  
the time 
a. 
Confident in a social setting? 
1 
2 
3 
4 
5 
b. 
Emotionally able to do the things that 
you want to do? 
1 
2 
3 
4 
5 
c. 
Emotionally healthy? 
1 
2 
3 
4 
5 
d. 
Of equal worth to other women? 
1 
2 
3 
4 
5 
e. 
Self-confident? 
1 
2 
3 
4 
5 
f. 
Feminine in your clothes? 
1 
2 
3 
4 
5 
g. 
Accepting of your body? 
1 
2 
3 
4 
5 
h. 
Normal?  
1 
2 
3 
4 
5 
i. 
Like other women? 
1 
2 
3 
4 
5 
j. 
Attractive? 
1 
2 
3 
4 
5 
 
Please check that you have answered all the questions before going on to the next page 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 41 
 
3. In the past 2 weeks, how often have you experienced: 
 
 
None of 
the time 
A little of 
the time 
Some of 
the time 
Most of 
the time 
All of  
the time 
a. 
Neck pain? 
1 
2 
3 
4 
5 
b. 
Upper back pain? 
1 
2 
3 
4 
5 
c. 
Shoulder pain? 
1 
2 
3 
4 
5 
d. 
Arm pain? 
1 
2 
3 
4 
5 
e. 
Rib pain? 
1 
2 
3 
4 
5 
f. 
Pain in the muscles of your chest? 
1 
2 
3 
4 
5 
g. 
Difficulty lifting or moving your arms? 
1 
2 
3 
4 
5 
h. 
Difficulty sleeping because of discomfort 
in your breast area? 
1 
2 
3 
4 
5 
i. 
Tightness in your breast area? 
1 
2 
3 
4 
5 
j. 
Pulling in your breast area?  
1 
2 
3 
4 
5 
k. 
Nagging feeling in your breast area? 
1 
2 
3 
4 
5 
l. 
Tenderness in your breast area? 
1 
2 
3 
4 
5 
m. 
Sharp pains in your breast area? 
1 
2 
3 
4 
5 
n. 
Shooting pains in your breast area?  
1 
2 
3 
4 
5 
o. 
Aching feeling in your breast area? 
1 
2 
3 
4 
5 
p. 
Throbbing feeling in your breast area? 
1 
2 
3 
4 
5 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (PRE OPERATIVE) 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 42 
4. In the past 2 weeks, with your abdomen (tummy area) in mind, how often have you experienced: 
 
 
None of 
the time 
A little of 
the time 
Some of 
the time 
Most of 
the time 
All of  
the time 
a. 
Difficulty sitting up because of abdominal 
muscle weakness (e.g. getting out of 
bed)? 
1 
2 
3 
4 
5 
b. 
Difficulty doing everyday activities 
because of abdominal muscle weakness 
(e.g. making your bed)? 
1 
2 
3 
4 
5 
c. 
Abdominal discomfort?  
1 
2 
3 
4 
5 
d. 
Abdominal bloating? 
1 
2 
3 
4 
5 
e. 
Lower back pain? 
1 
2 
3 
4 
5 
 
 
5. In the past 2 weeks, how satisfied or dissatisfied have you been with: 
 
 
Very 
Dissatisfie
d 
Somewhat 
Dissatisfie
d 
Somewhat 
Satisfied 
Very  
Satisfied 
a. 
How your abdomen looks? 
1 
2 
3 
4 
 
 
6. Thinking of your sexuality, how often do you generally feel: 
 
 
None of  
the time 
A little 
of the 
time 
Some of 
the time 
Most of 
the time 
All of  
the time 
Not 
Applicabl
e 
a. 
Sexually attractive in your 
clothes? 
1 
2 
3 
4 
5 
N/A 
b. 
Comfortable/at ease during 
sexual activity? 
1 
2 
3 
4 
5 
N/A 
c. 
Confident sexually? 
1 
2 
3 
4 
5 
N/A 
d. 
Satisfied with your sex-life? 
1 
2 
3 
4 
5 
N/A 
e. 
Confident sexually about how 
your breast(s) look when 
unclothed? 
1 
2 
3 
4 
5 
N/A 
f. 
Sexually attractive when 
unclothed? 
1 
2 
3 
4 
5 
N/A 
 
 
Please check that you have answered all the questions 
 
BREAST-Q© RECONSTRUCTION MODULE (PRE OPERATIVE) 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 43 
Appendix D: BREAST-Q© Reconstruction Module 
Postoperative Questionnaire 
Subject Number: ____________ Study Personnel: _________________________________  
 
Last Name: __________________________First Name: _____________________________    
 
MRN: ________________ DOB: ______________ Date: ___/___/_____ Time: ___________ 
 
The following questions are about your breasts and breast reconstruction surgery.  After reading 
each question, please circle the number in the box that best describes your situation.  If you are 
unsure how to answer a question, choose the answer that comes closest to how you feel.  Please 
answer all questions. 
 
1. With your breasts in mind, in the past 2 weeks, how satisfied or dissatisfied have you been 
with: 
 
Very 
Dissatisfied 
Somewhat 
Dissatisfied 
Somewhat  
Satisfied 
Very  
Satisfied 
e. 
How you look in the mirror clothed? 
1 
2 
3 
4 
f. 
The shape of your reconstructed breast(s) 
when you are wearing a bra? 
1 
2 
3 
4 
g. 
How normal you feel in your clothes? 
1 
2 
3 
4 
h. 
The size of your reconstructed breast(s)? 
1 
2 
3 
4 
i. 
Being able to wear clothing that is more 
fitted? 
1 
2 
3 
4 
j. 
How your breasts are lined up in relation 
to each other? 
1 
2 
3 
4 
k. 
How comfortably your bras fit? 
1 
2 
3 
4 
l. 
The softness of your reconstructed 
breast(s)? 
1 
2 
3 
4 
m. 
How equal in size your breasts are to each 
other? 
1 
2 
3 
4 
n. 
How natural your reconstructed breast(s) 
looks? 
1 
2 
3 
4 
o. 
How naturally your reconstructed breast(s) 
sits/hangs? 
1 
2 
3 
4 
p. 
How your reconstructed breast(s) feels to 
touch? 
1 
2 
3 
4 
q. 
How much your reconstructed breast(s) 
feels like a natural part of your body? 
1 
2 
3 
4 
r. 
How closely matched your breasts are to 
each other? 
1 
2 
3 
4 
s. 
How your reconstructed breast(s) look 
now compared to before you had any 
breast surgery? 
1 
2 
3 
4 
t. 
How you look in the mirror unclothed? 
1 
2 
3 
4 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 44 
This question is about breast reconstruction using IMPLANTS.  If you do not have an implant(s) 
please skip to question 3.  If you do have an implant(s), please answer question 2 below. 
 
2. In the past 2 weeks, how satisfied or dissatisfied have you been with: 
 
 
Very 
Dissatisfied 
Somewhat 
Dissatisfied 
Somewhat 
Satisfied 
Very  
Satisfied 
a. 
The amount of rippling (wrinkling) of your 
implant(s) that you can see? 
1 
2 
3 
4 
b. 
The amount of rippling (wrinkling) of your 
implant(s) that you can feel? 
1 
2 
3 
4 
 
 
3. These questions ask how you feel about the outcome of your breast reconstruction surgery.  
Please indicate how much you agree or disagree with each statement: 
 
 
Disagree 
Somewhat 
Agree 
Definitely 
Agree 
a. 
Having reconstruction is much better than the 
alternative of having no breast(s). 
1 
2 
3 
b. 
I would encourage other women in my situation to 
have breast reconstruction surgery. 
1 
2 
3 
c. 
I would do it again. 
1 
2 
3 
d. 
I have no regrets about having the surgery. 
1 
2 
3 
e. 
Having this surgery changed my life for the better. 
1 
2 
3 
f. 
The outcome perfectly matched my expectations. 
1 
2 
3 
g. 
It turned out exactly as I had planned.  
1 
2 
3 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 45 
4. With your breasts in mind, in the past 2 weeks, how often have you felt: 
 
 
None of 
the time 
A little of 
the time 
Some of 
the time 
Most of 
the time 
All of  
the time 
a. 
Confident in a social setting? 
1 
2 
3 
4 
5 
b. 
Emotionally able to do the things that you 
want to do? 
1 
2 
3 
4 
5 
c. 
Emotionally healthy? 
1 
2 
3 
4 
5 
d. 
Of equal worth to other women? 
1 
2 
3 
4 
5 
e. 
Self-confident? 
1 
2 
3 
4 
5 
f. 
Feminine in your clothes? 
1 
2 
3 
4 
5 
g. 
Accepting of your body? 
1 
2 
3 
4 
5 
h. 
Normal?  
1 
2 
3 
4 
5 
i. 
Like other women? 
1 
2 
3 
4 
5 
j. 
Attractive? 
1 
2 
3 
4 
5 
 
 
5. Thinking of your sexuality, since your breast reconstruction, how often do you generally feel: 
 
 
None of 
the time 
A little 
of the 
time 
Some of 
the time 
Most of 
the time 
All of  
the time 
Not 
Applicable 
a. 
Sexually attractive in your 
clothes? 
1 
2 
3 
4 
5 
N/A 
b. 
Comfortable/at ease during 
sexual activity? 
1 
2 
3 
4 
5 
N/A 
c. 
Confident sexually? 
1 
2 
3 
4 
5 
N/A 
d. 
Satisfied with your sex-life? 
1 
2 
3 
4 
5 
N/A 
e. 
Confident sexually about how 
your breast(s) look when 
unclothed? 
1 
2 
3 
4 
5 
N/A 
f. 
Sexually attractive when 
unclothed? 
1 
2 
3 
4 
5 
N/A 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 46 
6. In the past 2 weeks, how often have you experienced: 
 
 
None of 
the time 
A little of 
the time 
Some of 
the time 
Most of 
the time 
All of  
the time 
a. 
Neck pain? 
1 
2 
3 
4 
5 
b. 
Upper back pain? 
1 
2 
3 
4 
5 
c. 
Shoulder pain? 
1 
2 
3 
4 
5 
d. 
Arm pain? 
1 
2 
3 
4 
5 
e. 
Rib pain? 
1 
2 
3 
4 
5 
f. 
Pain in the muscles of your chest?  
1 
2 
3 
4 
5 
g. 
Difficulty lifting or moving your arms? 
1 
2 
3 
4 
5 
h. 
Difficulty sleeping because of discomfort 
in your breast area? 
1 
2 
3 
4 
5 
i. 
Tightness in your breast area? 
1 
2 
3 
4 
5 
j. 
Pulling in your breast area? 
1 
2 
3 
4 
5 
k. 
Nagging feeling in your breast area? 
1 
2 
3 
4 
5 
l. 
Tenderness in your breast area? 
1 
2 
3 
4 
5 
m. 
Sharp pains in your breast area? 
1 
2 
3 
4 
5 
n. 
Shooting pains in your breast area? 
1 
2 
3 
4 
5 
o. 
Aching feeling in your breast area? 
1 
2 
3 
4 
5 
p. 
Throbbing feeling in your breast area? 
1 
2 
3 
4 
5 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 47 
The following questions are about reconstruction using a TRAM or DIEP flap (i.e., reconstruction 
using skin and fat from your abdomen/tummy area).  If you do not have a TRAM or DIEP flap, 
please skip to question 10.  If you do have a TRAM or DIEP flap, please answer the following 
questions: 
 
 
7. In the past 2 weeks, with your abdomen (tummy area) in mind, how often have you experienced: 
 
 
None of 
the time 
A little of 
the time 
Some of 
the time 
Most of 
the time 
All of  
the time 
a. 
Difficulty sitting up because of abdominal 
muscle weakness (e.g. getting out of 
bed)? 
1 
2 
3 
4 
5 
b. 
Difficulty doing everyday activities 
because of abdominal muscle weakness 
(e.g. making your bed)? 
1 
2 
3 
4 
5 
c. 
Abdominal discomfort?  
1 
2 
3 
4 
5 
d. 
Abdominal bloating? 
1 
2 
3 
4 
5 
e. 
Abdominal bulging? 
1 
2 
3 
4 
5 
f. 
Tightness in your abdomen? 
1 
2 
3 
4 
5 
g. 
Pulling in your abdomen? 
1 
2 
3 
4 
5 
h. 
Lower back pain? 
1 
2 
3 
4 
5 
 
8. In the past 2 weeks, how satisfied or dissatisfied have you been with: 
 
 
Very 
Dissatisfied 
Somewhat 
Dissatisfied 
Somewhat 
Satisfied 
Very  
Satisfied 
a. 
How your abdomen looks? 
1 
2 
3 
4 
b. 
The position of your navel (belly button)? 
1 
2 
3 
4 
c. 
How your abdominal scars look? 
1 
2 
3 
4 
 
9. In the past 2 weeks, how satisfied or dissatisfied have you been with: 
 
 
Very 
Dissatisfied 
Somewhat 
Dissatisfied  
Somewhat 
Satisfied 
Very  
Satisfied 
a. 
How your abdomen feels now compared 
to before your surgery?  
1 
2 
3 
4 
b. 
How your abdomen looks now compared 
to before your surgery?  
1 
2 
3 
4 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 48 
This question is about NIPPLE reconstruction.  If you did not have nipple reconstruction, please 
skip to question 11.  If you did have nipple reconstruction, please answer question 10 below. 
 
10. In the past 2 weeks, how satisfied or dissatisfied are you with: 
 
 
Very 
Dissatisfied 
Somewhat 
Dissatisfied 
Somewhat 
Satisfied 
Very  
Satisfied 
a. The shape of your reconstructed nipple(s)? 
1 
2 
3 
4 
b. How your reconstructed nipple(s) and 
areola(s) look? 
1 
2 
3 
4 
c. How natural your reconstructed nipple(s) 
look? 
1 
2 
3 
4 
d. The color of your reconstructed nipple/areolar 
complex? 
1 
2 
3 
4 
e. The height (projection) of your reconstructed 
nipple(s)? 
1 
2 
3 
4 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 49 
11. How satisfied or dissatisfied were you with the information you received from your plastic 
surgeon about: 
 
 
Very 
Dissatisfied 
Somewhat 
Dissatisfied 
Somewhat  
Satisfied 
Very  
Satisfied 
a. 
How the breast reconstruction surgery was 
to be done? 
1 
2 
3 
4 
b. 
Healing and recovery time? 
1 
2 
3 
4 
c. 
Possible complications? 
1 
2 
3 
4 
d. 
The options you were given regarding 
types of breast reconstruction? 
1 
2 
3 
4 
e. 
The options you were given regarding 
timing of your breast reconstruction (i.e. 
same time as your mastectomy versus 
later)? 
1 
2 
3 
4 
f. 
The pros and cons of the timing of your 
breast reconstruction? 
1 
2 
3 
4 
g. 
How long the process of breast 
reconstruction would take from start to 
finish? 
1 
2 
3 
4 
h. 
What size you could expect your breasts 
to be after reconstructive surgery? 
1 
2 
3 
4 
i. 
How much pain to expect during recovery? 
1 
2 
3 
4 
j. 
What you could expect your breasts to 
look like after surgery? 
1 
2 
3 
4 
k. 
How long after reconstruction surgery it 
would take to feel like yourself/feel normal 
again? 
1 
2 
3 
4 
l. 
How the surgery could affect future breast 
cancer screening (e.g. mammogram, self 
examinations)? 
1 
2 
3 
4 
m. 
Lack of sensation in your reconstructed 
breast(s) and nipple(s)? 
1 
2 
3 
4 
n. 
What other women experience with their 
breast reconstruction surgery? 
1 
2 
3 
4 
o. 
What the scars would look like? 
1 
2 
3 
4 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 50 
12. These questions ask about your plastic surgeon.  Do you feel that he/she: 
 
 
Definitely 
Disagree 
Somewhat 
Disagree 
Somewhat 
Agree 
Definitely  
Agree 
a. 
Was competent? 
1 
2 
3 
4 
b. 
Gave you confidence? 
1 
2 
3 
4 
c. 
Involved you in the decision-making 
process? 
1 
2 
3 
4 
d. 
Was reassuring? 
1 
2 
3 
4 
e. 
Answered all your questions? 
1 
2 
3 
4 
f. 
Made you feel comfortable? 
1 
2 
3 
4 
g. 
Was thorough? 
1 
2 
3 
4 
h. 
Was easy to talk to? 
1 
2 
3 
4 
i. 
Understood what you wanted? 
1 
2 
3 
4 
j. 
Was sensitive? 
1 
2 
3 
4 
k. 
Made time for your concerns? 
1 
2 
3 
4 
l. 
Was available when you had concerns? 
1 
2 
3 
4 
 
Please check that you have answered all the questions before going on to the next page 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 51 
13. These questions ask about members of the medical team other than the surgeon (e.g. nurses 
and other doctors who looked after you in the hospital when you had your breast reconstruction 
surgery).  Did you feel that they: 
 
 
Definitely  
Disagree 
Somewhat 
Disagree 
Somewhat 
Agree 
Definitely 
Agree 
a. 
Were professional? 
1 
2 
3 
4 
b. 
Treated you with respect? 
1 
2 
3 
4 
c. 
Were knowledgeable? 
1 
2 
3 
4 
d. 
Were friendly and kind? 
1 
2 
3 
4 
e. 
Made you feel comfortable? 
1 
2 
3 
4 
f. 
Were thorough? 
1 
2 
3 
4 
g. 
Made time for your concerns? 
1 
2 
3 
4 
 
14. These questions ask about members of the office staff (e.g. secretaries and office nurses).   
Did you feel that they: 
 
 
Definitely  
Disagree 
Somewhat 
Disagree 
Somewhat 
Agree 
Definitely 
Agree 
a. 
Were professional? 
1 
2 
3 
4 
b. 
Treated you with respect? 
1 
2 
3 
4 
c. 
Were knowledgeable? 
1 
2 
3 
4 
d. 
Were friendly and kind? 
1 
2 
3 
4 
e. 
Made you feel comfortable? 
1 
2 
3 
4 
f. 
Were thorough? 
1 
2 
3 
4 
g. 
Made time for your concerns? 
1 
2 
3 
4 
 
Please check that you have answered all the questions 
 
BREAST-Q© RECONSTRUCTION MODULE (POST OPERATIVE) 
 
 
 
 
 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 52 
 
Appendix E:  RAND-36 Item Short Form Survey 
 
Subject Number: ____________ Study Personnel: _________________________________  
 
Last Name: __________________________First Name: _____________________________    
 
MRN: ________________ DOB: ______________ Date: ___/___/_____ Time: ___________ 
 
1. In general, would you say your health is: 
 
Excellent 
Very Good 
Good 
Fair 
Poor 
1 
2 
3 
4 
5 
 
 
2. Compared to one year ago, how would you rate your health in general now? 
 
Much better now 
than one year 
ago 
Somewhat better 
now than one 
year ago 
About the same 
Somewhat worse 
now than one 
year ago 
Much worse now 
than one year 
ago 
1 
2 
3 
4 
5 
 
 
The following items are about activities your might do during a typical day.  Does your health now 
limit you in these activities? If so, how much? 
 
 
 
Yes, 
Limited A 
Lot 
Yes, 
Limited A 
Little 
No, 
Not Limited 
At All 
3. Vigorous activities, such as running, lifting heavy 
objects, participating in strenuous sports 
1 
2 
3 
4. Moderate activities, such as moving a table, 
pushing a vacuum cleaner, bowling, or playing golf 
1 
2 
3 
5. Lifting or carrying groceries 
1 
2 
3 
6. Climbing several flights of stairs 
1 
2 
3 
7. Climbing one flight of stairs 
1 
2 
3 
8. Bending, kneeling, or stooping 
1 
2 
3 
9. Walking more than a mile 
1 
2 
3 
10. Walking several blocks 
1 
2 
3 
11. Walking one block 
1 
2 
3 
12. Bathing or dressing yourself 
1 
2 
3 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 53 
 
 
During the past 4 weeks, have you had any of the following problems with your work or other 
regular daily activities as a result of your physical health? 
 
 
Yes 
No 
13. Cut down the amount of time you spent on work or other 
activities 
1 
2 
14. Accomplished less than you would like 
1 
2 
15. Were limited in the kind of work or other activities 
1 
2 
16. Had difficulty performing the work or other activities (for 
example, it took extra effort) 
1 
2 
 
 
During the past 4 weeks, have you had any of the following problems with your work or other 
regular daily activities as a result of any emotional problems (such as feeling depressed or 
anxious)? 
 
 
Yes 
No 
17. Cut down the amount of time you spent on work or other 
activities 
1 
2 
18. Accomplished less than you would like 
1 
2 
19. Didn't do work or other activities as carefully as usual 
1 
2 
 
 
20. During the past 4 weeks, to what extent has your physical health or emotional problems 
interfered with your normal social activities with family, friends, neighbors, or groups? 
 
Not at all 
Slightly 
Moderately 
Quite a bit 
Extremely 
1 
2 
3 
4 
5 
 
 
21. How much bodily pain have you had during the past 4 weeks? 
 
None 
Very Mild 
Mild 
Moderate 
Severe 
Very Severe 
1 
2 
3 
4 
5 
6 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 54 
 
22. During the past 4 weeks, how much did pain interfere with your normal work (including both 
work outside the home and housework)? 
 
Not at all 
Slightly 
Moderately 
Quite a bit 
Extremely 
1 
2 
3 
4 
5 
 
 
These questions are about how you feel and how things have been with you during the past 4 
weeks. For each question, please give the one answer that comes closest to the way you have 
been feeling.  How much of the time during the past 4 weeks . . .  
 
 
All of 
the Time 
Most of 
the Time 
A Good 
Bit of 
the Time 
A Little 
of the 
Time 
None of 
the Time 
23. Did you feel full of pep? 
1 
2 
3 
4 
5 
24. Have you been a very nervous person? 
1 
2 
3 
4 
5 
25. Have you felt so down in the dumps that 
nothing could cheer you up? 
1 
2 
3 
4 
5 
26. Have you felt calm and peaceful? 
1 
2 
3 
4 
5 
27. Did you have a lot of energy? 
1 
2 
3 
4 
5 
28. Have you felt downhearted and blue? 
1 
2 
3 
4 
5 
29. Did you feel worn out? 
1 
2 
3 
4 
5 
30. Have you been a happy person? 
1 
2 
3 
4 
5 
31. Did you feel tired? 
1 
2 
3 
4 
5 
 
 
32. During the past 4 weeks, how much of the time has your physical health or emotional 
problems interfered with your social activities (like visiting with friends, relatives, etc.)? 
 
All of the time 
Most of the time 
Some  
of the time 
A little  
of the time 
None of the time 
1 
2 
3 
4 
5 
 
 
 
 
 
 
 
 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 55 
How TRUE or FALSE is each of the following statements for you? 
 
 
Definitely 
True 
Mostly 
True 
Don’t 
Know 
Mostly 
False 
Definitely 
False 
33. I seem to get sick a little easier than 
other people. 
1 
2 
3 
4 
5 
34. I am as healthy as anybody I know. 
1 
2 
3 
4 
5 
35. I expect my health to get worse. 
1 
2 
3 
4 
5 
36. My health is excellent. 
1 
2 
3 
4 
5 
 
 
Thank you for participating in this survey.   
Please make sure you have answered all of the questions. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Paravertebral Blocks to Decrease Breast Reconstruction Pain  
Principal Investigator: Gedge Rosson, MD 
Protocol Number: NA_00075957 
 
 
 
 
 
 
 
Version:  February 16, 2017 
 
Page 56 
Appendix F:  Quick DASH Questionnaire 
 
Subject Number: ____________ Study Personnel: _________________________________  
 
Last Name: __________________________First Name: _____________________________    
 
MRN: ________________ DOB: ______________ Date: ___/___/_____ Time: ___________ 
 
 

ICF_000.pdf: 
 
Approved September 29, 2015 
Date: September 29, 2015 
Principal Investigator: Gedge Rosson M.D 
Application No.:  NA_000759500075957 
. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
RESEARCH PARTICIPANT INFORMED CONSENT AND PRIVACY 
AUTHORIZATION FORM 
 
Protocol Title:  
Pre-operative Paravertebral Blocks to Decrease Post-operative 
Pain Following Mastectomy with Immediate Tissue Expander 
Reconstruction 
 
Application No.:   
NA_00075957 
 
Principal Investigator: Dr. Gedge Rosson  
Department of Plastic & Reconstructive Surgery  
The Johns Hopkins Hospital Outpatient Center  
601 N. Caroline Street, McElderry 8161  
Baltimore, MD 21287  
Phone: 410-955-9472  
Fax: 410-502-3092 
  
1. 
What you should know about this study: 
• You are being asked to join a research study. This consent form explains the research study and your 
part in it. Please read it carefully and take as much time as you need. Ask your study doctor or the 
study team to explain any words or information that you do not understand. 
• You are a volunteer.  If you join the study, you can change your mind later.  There will be no penalty 
or loss of benefits if you decide to quit the study.   
• During the study, we will tell you if we learn any new information that might affect whether you 
wish to continue to participate. 
• If we think your participation in this study may affect your clinical care, information about your 
study participation will be included in your medical record, which is used throughout Johns Hopkins.   
Doctors outside of Johns Hopkins may not have access to this information.  You can ask the research 
team to send this information to any of your doctors. 
• When Johns Hopkins is used in this consent form, it includes The Johns Hopkins University, The 
Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center, Howard County General Hospital, 
Johns Hopkins Community Physicians, Suburban Hospital, Sibley Memorial Hospital and All 
Children’s Hospital.  
• A description of this clinical trial will be available on http://www.ClinicalTrials.gov,at 
www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that 
can identify you. At most, the Web site will include a summary of the results. You can search this 
Web site at any time.  
• If you would like to review the information for this study, or a summary of the results, ask the study 
team doctor for the ClinicalTrials.gov study registration number. 
If you are using Epic for this study, fax a copy 
of the signed consent form to 410-367-7382. 
 
 
 
 
 
Patient I.D. plate 
 
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• During this study, you will not have access to certain medical information and test results collected 
for study purposes.  If an emergency occurs while you are in the study, medical information needed 
for your treatment can be made available to your study physician and other physicians who treat you.  
When the study is completed, all the information in your medical record will be available to you. 
 
2. 
Why is this research being done? 
This research is being done to see how well a pain medicine (ropivacaine) treats pain after breast 
reconstruction when it is injected near your spine to numb the nerves going to your chest. Previous 
studies have shown varying results in reducing pain, nausea, and sleeping problems after surgery.  
 
The Food and Drug Administration (FDA) has approved the use of ropivacaine for local or regional pain 
relief for surgery. Also, ropivacaine is used in diagnostic and therapeutic procedures. In pregnant 
women ropivacaine is used for procedures performed during delivery.  
 
People with planned breast removal followed by immediate breast reconstruction with tissue expanders 
may join this study. 
 
How many people will be in this study? 
About 70 women will join this study. 
 
3. 
What will happen if you join this study? 
If you agree to be in this study, we will ask you to do the following things:  
 
A member of the study staff will ask you to complete some questionnaires. These questionnaires are 
used to determine your overall quality of life before your surgery. The staff member will also work with 
you to find out your overall pain level before your surgery.  
 
Before your first breast surgery you will be randomly (by chance, like a flip of a coin) assigned to one of 
two groups: the study drug administration group or the placebo group.  
 
• If you are randomized to the study drug administration group, you will receive ropivacaine 
injections. The standard vital sign monitors will be placed. You will be asked to sit. After 
administering light intravenous sedation, the skin of your back will be cleaned with antiseptic 
solution. The anesthesiologist will locate where you will receive the injections (the spaces between 
your vertebrae) by touching your thoracic spine (mid-back). Once located, a local anesthesia will be 
applied to each side of your mid-back after which you will receive the study injections. About 6-7 
injections will be placed on each side of your mid back and each injection will be about 5ml (about 1 
teaspoon). The procedure will take about 10-15 minutes. After you are given the injections, you will 
be asked to lie down. Please refer to the attached information sheet on paravertebral blocks for more 
information. 
 
• If you are randomized to the placebo group, you will receive injections of an inactive substance (like 
salt water) that looks like the study drug but contains no active study drug. The standard vital sign 
monitors will be placed. You will be asked to sit. After administering light intravenous sedation, the 
skin of your back will be cleaned with antiseptic solution. The anesthesiologist will locate where you 
will receive the injections (the spaces between your vertebrae) by touching your thoracic spine (mid-
back). Once located, a local anesthesia will be applied to each side of your mid-back. after which 
you will receive the study injections. About 6-7 injections will be placed on each side of your mid 
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back and each injection will be about 5ml (about 1 teaspoon). The procedure will take about 10-15 
minutes. After you are given the injections, you will be asked to lie down.  
 
You will have an equal chance of being in either group.  Neither you nor your doctor can choose the 
study group. Additionally, this study is “blinded” which means that neither you nor your doctors but 
only the study staff will know to which study group you have been assigned. However, in an emergency 
this information can be found and given to your doctors.  
 
You will receive general anesthesia as you normally would and your breast removal surgery and breast 
reconstruction procedure will be done, per standard surgical techniques.   
 
Following the surgery, standard pain control medicine will be available to you, per standard of care. 
Because you are in this study, you will be asked to complete a few short questionnaires. These 
questionnaires will tell us about any pain you might have. If you are able to go home the first or second 
day after your surgery, a study team member will call you to ask you some questions by phone. These 
questions will be about your pain, pain medicine use, and any problems you might be having. The 
expected length of hospital stay after your surgery is about one day. 
 
When you return for your normal follow-up visit one week (7 days) after the surgery, a study team 
member will also meet with you to ask you about any problems you may be having and about any pain 
medicine you have been using. Additionally, you will be asked to complete three short questionnaires.  
  
When you return for your normal follow-up visit 3 months (90-days) after your surgery, you will be 
asked to complete four short questionnaires. These questionnaires will tell the study team how you are 
doing and about any problems you might be having.  
 
Two and 4 years after your surgery we will try to contact you over the phone and ask you to complete 
the same questionnaires. 
 
How long will you be in the study? 
You will be in this study for up to 4 years. 
 
4. 
What are the risks or discomforts of the study? 
 
Risks of Ropivacaine:  
The study drug, ropivacaine, may cause certain side effects with the following levels of likelihood:  
• Likely:  
o None  
 
• Less likely (occurs in more than 10 of every 100 patients):  
o Low blood pressure  
o Irregular heartbeat  
o Nausea and vomiting  
o Back pain  
 
 
 
 
 
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• Unlikely (occurs in 1-10 of every 100 patients):  
o High blood pressure  
o Chest pain  
o Fever  
o Headache  
o Dizziness  
o Chills  
o Anxiety  
o Lightheadedness  
o Itching  
o Difficulty urinating  
o Tingling around your mouth  
o Numbness of your tongue  
 
• Rare (occurs in less than 1 of every 100 patients, usually in the context of overdose or inadvertent 
intravascular injections):  
o Allergic reactions  
o Heart attack  
o Rash  
o Muscle stiffness and/or twitching  
o Seizure (uncontrollable shaking of your body)  
o Hearing problems  
o Vision problems  
o Speech problems  
  
Risks of Study Procedures (will apply to both arms):  
Possible problems caused directly by being stuck with a needle (whether you get the study drug or 
placebo) include: severe bleeding (less than 3 people out of 100), collapsed lung (less than 1 out of 200), 
headache after spinal injection (rarely), or infection in the fluid that surrounds your brain and spine 
(rarely). Rarely, brain abscesses can occur. 
 
Risks of your breast removal surgery and reconstruction procedure will be explained in your surgical 
consent form. There are no increased risks related to the surgery and reconstruction procedure.   
 
You may feel more anxious than usual simply because you know you are in a research study.  
 
There is the risk that information about you may become known to people outside of this study.  
Although all efforts will be made to keep the study information confidential, there is always the possible 
loss of confidentiality.  
 
You may get tired or bored when we are asking you questions or you are completing questionnaires. 
You do not have to answer any question you do not want to answer.  
 
Unknown Risks:  
There may be side effects and discomforts that are not yet known.   
 
 
 
 
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5. 
Are there benefits to being in the study? 
You may or may not benefit from being in this study. You may experience less pain after your surgery 
but this cannot be guaranteed. If you are randomized to receive placebo, no benefit is expected. If you 
take part in this study, you may help others in the future. 
 
6. 
What are your options if you do not want to be in the study? 
You do not have to join this study to receive the paravertebral block with your breast removal surgery 
and breast reconstruction procedure.  
 
You do not have to join this study.  If you do not join, your care at Johns Hopkins will not be affected. 
 
7. 
Will it cost you anything to be in this study?   
No. You or your insurance company will not be billed for the paravertebral block procedure. 
 
8. 
Will you be paid if you join this study? 
No. 
 
9. 
Can you leave the study early? 
• You can agree to be in the study now and change your mind later. 
• If you wish to stop, please tell us right away. 
• Leaving this study early will not stop you from getting regular medical care.  
 
If you leave the study early, Johns Hopkins may use or give out your health information that it has 
already collected if the information is needed for this study or any follow-up activities.  
 
10. 
Why might we take you out of the study early?  
You may be taken out of the study if: 
• Staying in the study would be harmful. 
• You need treatment not allowed in the study. 
• You fail to follow instructions. 
• You become pregnant. 
• The study is cancelled. 
• There may be other reasons to take you out of the study that we do not know at this time.  
 
If you are taken out of the study early, Johns Hopkins may use or give out your health information that it 
has already collected if the information is needed for this study or any follow-up activities. 
 
11. 
How will your privacy be protected?  
We have rules to protect information about you.  Federal and state laws and the federal medical Privacy 
Rule also protect your privacy.  By signing this form you provide your permission, called your 
“authorization,” for the use and disclosure of information protected by the Privacy Rule. 
 
The research team working on the study will collect information about you.  This includes things learned 
from the procedures described in this consent form.  They may also collect other information including 
your name, address, date of birth, and information from your medical records (which may include 
information about HIV status, drug, alcohol or STD treatment, genetic test results, or mental health 
treatment). 
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The research team will know your identity and that you are in the research study.  Other people at Johns 
Hopkins, particularly your doctors, may also see or give out your information. We make this information 
available to your doctors for your safety.    
 
People outside of Johns Hopkins may need to see or receive your information for this study.  Examples 
include government agencies (such as the Food and Drug Administration), safety monitors, other sites in 
the study and companies that sponsor the study.  
 
If you are in a cancer study that receives federal funding, the National Cancer Institute (NCI) now 
requires that we report identifiable information (such as, zip code) about your participation.  You may 
contact the NCI if you have questions about how this information is used.  
 
We cannot do this study without your authorization to use and give out your information.  You do not 
have to give us this authorization.  If you do not, then you may not join this study. 
 
We will use and disclose your information only as described in this form and in our Notice of Privacy 
Practices; however, people outside Johns Hopkins who receive your information may not be covered by 
this promise or by the federal Privacy Rule.  We try to make sure that everyone who needs to see your 
information keeps it confidential – but we cannot guarantee that your information will not be re-
disclosed. 
 
The use and disclosure of your information has no time limit. You may revoke (cancel) your permission 
to use and disclose your information at any time by notifying the Principal Investigator of this study by 
phone or in writing.  If you contact the Principal Investigator by phone, you must follow-up with a 
written request that includes the study number and your contact information.  The Principal 
Investigator’s name, address, phone and fax information are on page one of this consent form.  
 
If you do cancel your authorization to use and disclose your information, your part in this study will end 
and no further information about you will be collected. Your revocation (cancellation) would not affect 
information already collected in the study, or information we disclosed before you wrote to the Principal 
Investigator to cancel your authorization. 
 
12. 
Will the study require any of your other health care providers to share your health 
information with the researchers of this study? 
As a part of this study, the researchers may ask to see your health care records from your other health 
care providers.   
 
You will be asked to give us a list of other health care providers that you use.  
 
13. 
What treatment costs will be paid if you are injured in this study?  
Johns Hopkins does not have a program to pay you if you are hurt or have other bad results from being 
in the study.  However, medical care at Johns Hopkins is open to you as it is to all sick or injured people. 
 
The costs for any treatment or hospital care you receive as the result of a study-related injury that are not 
covered by a health insurer will be billed to you. 
 
By signing this form you will not give up any rights you have to seek compensation for injury.  
 
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14. 
What other things should you know about this research study? 
a. What is the Institutional Review Board (IRB) and how does it protect you?  
The Johns Hopkins Medicine IRB is made up of: 
• Doctors 
• Nurses 
• Ethicists 
• Non-scientists 
• and people from the local community.  
 
The IRB reviews human research studies. It protects the rights and welfare of the people taking part 
in those studies.  You may contact the IRB if you have questions about your rights as a participant or 
if you think you have not been treated fairly.  The IRB office number is 410-955-3008. You may 
also call this number for other questions, concerns or complaints about the research. 
 
When the Johns Hopkins School of Medicine Institutional Review Board (IRB) reviews a study at 
another site, that site (institution) is solely responsible for the safe conduct of the study and for 
following the protocol approved by the Johns Hopkins IRB.   
 
b. What do you do if you have questions about the study?    
Call the principal investigator, Dr. Gedge Rosson at 410-955-9477. If you wish, you may contact the 
principal investigator by letter or by fax.  The address and fax number are on page one of this 
consent form. If you cannot reach the principal investigator or wish to talk to someone else, call the 
IRB office at 410-955-3008.   
 
c. What should you do if you are injured or ill as a result of being in this study?  
If you think you are injured or ill because of this study, call Dr. Gedge Rosson at 410-955-9477 during 
regular office hours.  
 
If you have an urgent medical problem related to your taking part in this study call 410-550-0500, 
and ask to speak with the plastic surgery resident on call. 
 
 
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15. 
What does your signature on this consent form mean?  
• 
Your signature on this form means that: You understand the information given to you in this form, you  
• You accept the provisions in the form and you 
You agree to join the study. You will not give up any legal rights by signing this consent form.  
 
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Participant                                                                           (Print Name)                                                 
 
Date/Time  
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Person Obtaining Consent                                                  (Print Name)                                               
 
Date/Time 
 
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; A COPY MUST BE GIVEN 
TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410-367-7382; IF YOU ARE NOT USING EPIC 
A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED).  
 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN THE CONSENT OF RESEARCH 
PARTICIPANTS. 
 
 
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DOCUMENTATION OF PHYSICIAN/MID-LEVEL PROVIDER CONSENT 
 
My signature below indicates that I have discussed the risks, benefits, and alternatives, answered any 
questions, and believe the participant is able to make an informed choice to join the study. 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Physician/Mid-Level Provider                     (Print Name)                                                                     
 
Date/Time   
 
 
 
 
 
________________________________________________________________________________________________________________________ 
Signature of Participant                                                    (Print Name)                                                                    
 
Date/Time     
 
 
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; A COPY MUST BE GIVEN 
TO THE PARTICIPANT; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410-367-7382; IF YOU ARE NOT USING EPIC 
A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD (UNLESS NO MEDICAL RECORD EXISTS OR WILL BE CREATED).  
 
 
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN THE CONSENT OF RESEARCH 
PARTICIPANTS. 
 
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