Conditions: Breast Cancer Breast Cancer Female Cancer of Breast
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 134
Healthy volunteers: no

Brief summary:
In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.

Detailed description:

Arms:
arm 1: * PECS I \& II block will be administered preoperatively
* For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
* To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
* Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age \< 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist arm 2: * A sham block (normal saline) will be placed preoperatively
* To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
* Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age \< 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.

Interventions: intervention 1: Bupivacaine intervention 2: Gabapentin intervention 3: Celecoxib intervention 4: Acetaminophen intervention 5: Midazolam intervention 6: Fentanyl
Intervention descriptions: intervention 1: -Given after general anesthesia intervention 2: * As per routine care
* Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years. intervention 3: * As per routine care
* Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
* Naproxen will be substituted for celecoxib in patients with sulfa allergies. intervention 4: -As per routine care intervention 5: -As per routine care intervention 6: -As per routine care

Protocol document:
Prot_SAP_000.pdf: 
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PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery 
  
Principal Investigator:  Ryan C Guffey, MD1   
Assistant Professor 
Washington University School of Medicine 
Department of Anesthesiology 
660 S. Euclid Ave., Campus Box 8054 
St. Louis, MO 63110 
Voice: (314) 286-2883 
E-mail: rguffey@wustl.edu 
 
 
 
Co-Investigators:  Mitchell E Fingerman MD1, Erin Gibbons MD1, Molly Vila MD1, Arbi Ben Abdallah1, Rebecca L Aft 
MD2, Amy E Cyr MD2, Todd Rice, MD, Julie A Margenthaler MD2, Simon Haroutounian PhD MSc1, Michael S Avidan 
MBBCh1 
 
 
 
 
Original Version:  January 16, 2017 
HRPO #: 201703053 
 
 
 
1 Department of Anesthesiology, Washington University School of Medicine, St. Louis, Missouri, USA 
2 Department of Surgery, Plastic and Reconstructive Surgery Division, Washington University School of Medicine, 
St. Louis, Missouri, USA 
 
 


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PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery 
Protocol Revision History 
 
Initial Approval Version 
03/27/2017 
Amendment #1 Version Date 
05/10/2017 
Amednment #2 Version Date 
06/19/2017 
Amendment #3 Version Date 
02/27/2018 
Amendment #4 Version Date 
2/11/2019 
Amendment #5 Version Date 
2/26/2019 
 
 
 
 


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PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery 
SCHEMA 
 
 
 
 
160 Patients enrolled 
and consented to PECS 
study 
Preop holding 
80 Patients 
randomized to control 
80 Patients 
randomized to PECS 
2 weeks 
Baseline surveys 
30 days 
6 months 
1 year 
1 year 
 Up to 80 patients per group BPI with HCAHPS at surgical clinic  
Up to 80 patients per group SATISFY SOS Survey (mailed) 
Up to 80 patients per group BPI with HCAHPS at surgical clinic  
Up to 80 patients per group BPI with HCHAPS at surgical clinic  
Up to 80 patients per group SATISFY SOS Survey (mailed) 
Preop Clinic 
Preop Clinic 
Aim 1 
 
Aim 2 
 


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Abstract 
 
Introduction: Persistent postoperative pain affects up to 60% of patients after breast cancer surgery.  Breast 
sparing surgical options such as lumpectomy with sentinel lymph node biopsy are still associated with persistent 
postoperative pain rates above 20%.  This can lead to limitations in ability to function and work as well as 
deterioration of quality of life and higher medical care costs.  Paravertebral nerve blocks have been shown to 
significantly decrease this risk, but paravertebral blocks are difficult to perform and can be associated with 
significant morbidity.  In 2012 Dr. Rafael Blanco introduced the pectoral nerve block (PECS) as an alternative 
method of decreasing pain after breast surgery.  While it has been shown to decrease acute postoperative pain, it is 
unknown if it decreases chronic postoperative pain in the longer term.   
 
Methods: In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery 
involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, 
celecoxib, and gabapentin.  Eighty subjects will also be randomized to receive a PECS I and II block preoperatively.  
All patients will receive general anesthesia including fentanyl for analgesia (or other opioid if allergic to fentanyl).  
Subjects will be assessed at baseline and 1 year postoperatively with a modified Brief Pain Inventory to look for 
differences between cohorts (with PECS block or without), for incidence and severity of persistent postoperative 
pain.  All patients will also be assessed at baseline and 1 year using Veterans RAND 12 questionnaire collected with 
the SATISFY SOS survey for difference in quality of life (WUSTL IRB# 201203088, NCT02032030). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Table of Contents 
SCHEMA ........................................................................................................................................................................... 3 
1 
BACKGROUND ......................................................................................................................................................... 6 
2 
OBJECTIVES .............................................................................................................................................................. 6 
2.1 
Primary Objective ............................................................................................................................................ 6 
2.2 
Exploratory Objective ...................................................................................................................................... 6 
3 
PATIENT SELECTION ................................................................................................................................................ 6 
3.1 
Inclusion Criteria ............................................................................................................................................. 6 
3.2 
Exclusion Criteria ............................................................................................................................................. 7 
3.3 
Inclusion of Women and Minorities ................................................................................................................ 7 
4 
REGISTRATION PROCEDURES .................................................................................................................................. 7 
4.1 
Confirmation of Patient Eligibility ................................................................................................................... 7 
4.2 
Patient Registration in the Siteman Cancer Center OnCore Database ........................................................... 8 
4.3 
Assignment of UPN ......................................................................................................................................... 8 
4.4 
Randomization and Blinding ........................................................................................................................... 8 
5 
METHODS ................................................................................................................................................................ 8 
5.1 
Primary Intervention – PECS Blocks ................................................................................................................ 8 
5.2 
Multimodal Analgesia and Perioperative Protocol ......................................................................................... 9 
5.3 
Evaluability .................................................................................................................................................... 10 
5.4 
Duration of Follow-Up ................................................................................................................................... 10 
6 
REGULATORY AND REPORTING REQUIREMENTS .................................................................................................. 10 
6.1 
Definitions ..................................................................................................................................................... 11 
6.2 
Reporting to the Human Research Protection Office (HRPO) at Washington University ............................. 16 
6.3 
Reporting to the Quality Assurance and Safety Monitoring Committee (QASMC) at Washington University
 
16 
6.4 
Timeframe for Reporting Required Events ................................................................................................... 16 
7 
PHARMACEUTICAL INFORMATION ....................................................................................................................... 17 
7.1 
Bupivacaine HCl ............................................................................................................................................. 17 
8 
DATA COLLECTION ................................................................................................................................................ 18 
9 
STUDY CALENDAR.................................................................................................................................................. 18 
10 DATA SUBMISSION SCHEDULE .............................................................................................................................. 19 
11 OUTCOME MEASURES ........................................................................................................................................... 20 
11.1 
Severity of postoperative pain ...................................................................................................................... 20 
11.2 
Quality of life ................................................................................................................................................. 20 
12 DATA AND SAFETY MONITORING ......................................................................................................................... 20 
13 STATISTICAL CONSIDERATIONS ............................................................................................................................. 21 
13.1 
Statistical Analysis and Power ....................................................................................................................... 21 
13.2 
Limitations ..................................................................................................................................................... 21 
14 References ............................................................................................................................................................. 22 
Appendix A: Modified BPI Baseline ............................................................................................................................... 23 
Appendix B: Modified BPI with HCAHPS follow-up survey ........................................................................................... 26 
Appendix C: Pain Scale .................................................................................................................................................. 30 
 
 


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1 
BACKGROUND 
 
Breast cancer is the second most common cancer among women in the United States with approximately 250,000 
new cases each year.(1) The primary treatment is surgical intervention, which can lead to high rates of persistent 
postoperative pain (PPP).(2)  Twenty-five to 60% of patients will experience chronic pain depending on 
treatment.(3)  For modified radical mastectomy, 50% of patients develop chronic pain with impaired quality of 
life.(4)  Breast conserving therapy (partial mastectomy) is associated with less pain overall, but still results in a 
significant PPP rate of 25%.  Due to an average 5-year survival rate of 89%, there are nearly 3 million women living 
in the US who have current or treated breast cancer. (5) Consequently, chronic pain following breast cancer surgery 
likely affects over 500,000 women, leading to hundreds of millions of dollars in medical costs as well as loss of 
ability to work and deterioration in quality of life. (6) Paravertebral nerve blocks have been shown to substantially 
decrease the incidence of PPP by 44-86%. (7,8,9) However, paravertebral blocks are difficult to perform and can be 
associated with significant morbidity.  In 2012 the Pectoral Nerve blocks I and II (PECS I and II) were introduced as 
safer and easier methods of decreasing pain after breast surgery.(10)  While PECS blocks have been shown to 
decrease acute postoperative pain,(11) it is unknown if they decrease pain in the longer term. 
 
Our long-term goal is to optimize the perioperative pain management of breast cancer surgery, to both minimize 
acute and chronic postoperative pain and maximize patient satisfaction in the most cost effective manner. Our 
hypothesis is that PECS blocks, compared with multimodal analgesia, will decrease persistent postoperative pain 
and improve patient reported quality of life.  The rationale is that since paravertebral blocks have been shown to 
decrease both acute and chronic postoperative pain, and PECS blocks have been shown to decrease acute pain, it is 
likely that PECS blocks also decrease chronic postoperative pain.  
 
 
2 
OBJECTIVES 
 
2.1 
Primary Objective 
 
To determine whether PECS I and II blocks decrease persistent postoperative pain compared with multimodal 
analgesia.  Pain will be measured by the Brief Pain Inventory. 
 
2.2 
Secondary Objective 
 
To determine the effects of PECS blocks on postoperative quality of life, as self-reported by patients.  QOL 
will be measured by the Veterans RAND 12 questionnaire collected in the SATISFY-SOS study. 
 
 
3 
PATIENT SELECTION 
 
3.1 
Inclusion Criteria 
 
1. Scheduled to undergo one of the following elective breast cancer surgeries at Barnes-Jewish Hospital:  
a. unilateral axillary dissection 
b. unilateral modified radical mastectomy 
c. mastectomy with same day unilateral reconstruction 
d. unilateral sentinel lymph node biopsy (SLNB) 
e. partial mastectomy with unilateral SLNB 
f. simple mastectomy with unilateral SLNB  
2. At least 18 years of age. 


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3. Able to understand and willing to sign an IRB-approved written informed consent document. 
4. Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030). 
 
 
3.2 
Exclusion Criteria 
 
1. Planned for bilateral axillary or bilateral reconstruction surgery. 
2. Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel 
lymph node biopsy. 
3. Pre-existing pain in the axilla affecting ability to use extremity for activities of daily living or requiring 
medication for treatment 
4. Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated 
transaminase levels.   
5. Known contraindications to peripheral nerve block placement. 
6. Pregnant or breastfeeding. 
7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to amide 
local anesthetics, acetaminophen or dexamethasone. 
8. Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor 
surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy) 
 
3.3 
Inclusion of Women and Minorities 
 
Women and members of all races and ethnic groups are eligible for this trial. 
 
3.4 
Alternative to study enrollment in SATISFY-SOS 
 
Patients that choose not to enroll in the SATISFY-SOS trial and thus ineligible to participate in this study will 
be given high quality standard of care with medications and regional anesthesia prescribed at the discretion 
of the surgeon and anesthesiologist.  Currently, most patients undergoing elective, surgical breast 
procedures are not administered a nerve block, but it is available on request.   
 
 
4 
REGISTRATION PROCEDURES 
 
Patients must not start any protocol intervention prior to registration through the Siteman Cancer Center. 
 
The following steps must be taken before registering patients to this study: 
 
1. Confirmation of patient eligibility 
2. Registration of patient in the Siteman Cancer Center OnCore database 
3. Assignment of unique patient research identification number (UPN) 
 
4.1 
Confirmation of Patient Eligibility 
 
Confirm patient eligibility by collecting the information listed below: 
 
1. 
Registering MD’s name 
2. 
Patient’s race, sex, and DOB 
3. 
Three letters (or two letters and a dash) for the patient’s initials 
4. 
Copy of signed consent form 
5. 
Completed eligibility checklist, signed and dated by a member of the study team 


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6. 
Copy of appropriate source documentation confirming patient eligibility 
 
4.2 
Patient Registration in the Siteman Cancer Center OnCore Database 
 
All patients must be registered through the Siteman Cancer Center OnCore database. 
 
4.3 
Assignment of UPN 
 
Each patient will be identified with a unique patient number (UPN) for this study.  All data will be recorded with this 
identification number on the appropriate CRFs. 
 
4.4 
Randomization and Blinding 
 
There will be two blocks of patients based upon type of surgical breast procedure. Block A will contain patients that 
are scheduled for surgical breast reconstruction, axillary dissection, and modified radical mastectomy.  Block B will 
contain patients scheduled for all other eligible breast procedures. Each block of consented subjects will undergo 
separate 1:1 randomization to either PECS block or no PECS block. All subjects in both blocks will undergo identical 
preoperative, intraoperative and postoperative analgesic regimen, surveys and data collection. An unblinded 
member of the study team will generate the randomization assignment list for each block using online Research 
Randomizer (https://www.randomizer.org/). The randomized list for both cohorts will be provided to 
Investigational Drug Services (IDS), who will provide study drug syringes containing either bupivacaine or placebo 
per the randomization assignment. Prior to the participant’s surgery, the research coordinator will provide 
Investigational Drug Services (IDS) with a copy of the subjects signed informed consent and study UPN number, 
along with appropriate Surgery Block as determined by type of planned surgical procedure. The patient, regional 
anesthesiologist, data collection team, anesthesia team, surgeon, and postoperative acute care unit (PACU) team 
will be blinded to group assignment.   The regional anesthesiologist will also be provided with a sealed envelope 
that indicates the study drug, if it should be considered in the subject’s best interest to break the blind. The blinding 
will be opened to the statistician following study completion for all subjects. The blind will be opened completely 
after follow-up is complete. 
 
5 
METHODS 
 
This study is a pragmatic pilot double-blinded randomized placebo controlled trial that will enroll up to 160 
evaluable patients who will undergo elective breast cancer surgery at Barnes Jewish Hospital North.  Participants 
will be randomized to receive either preoperative PECS blocks or sham placebo PECS blocks.  Both groups will 
receive multimodal analgesia in addition to the study procedure.  Participants will be assessed at enrollment with 
baseline surveys, then later at 2 weeks, 30 days, 6 months, and 1 year after surgery.  The primary outcome measure 
will be the severity of postoperative pain at 12 months by modified Brief Pain Inventory (BPI).  Study patients will 
also be enrolled in the Systematic Assessment and Targeted Improvement of Services Following Yearly Surgical 
Outcomes Surveys (SATISFY-SOS) trial clinicaltrials.gov (HRPO# 201203088, NCT02032030).  Data from the SATISFY-
SOS study will be used to assess patients’ quality of life at 1 year and to provide additional baseline information for 
confounder adjustment.  Figure 1 outlines the study design of this proposed research.  The trial will be registered at 
clinicaltrials.gov after IRB approval. Data reports from the SATISFY-SOS study will be generatedatvarious time points 
throughout the study for subjects enrolled to this protocol. 
 
5.1 
Primary Intervention – PECS Blocks 
 
Preoperative performance of PECS blocks is the primary intervention to which patients will be randomized.  For 
patients in the PECS group, a PECS I and II block will be administered with standard monitoring per usual protocol in 
either the preoperative holding area, or in the operating room after administration of general anesthesia before 
surgical incision.  For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine 


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(maximum 10mL).  The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL).  If 
there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 
0.2mL/kg of 0.375% bupivacaine (maximum 20mL).  It is common for patients scheduled for a modified radical 
mastectomy to also be scheduled for a prophylactic simple mastectomy on the other side.  For patients in the 
multimodal group a sham block (normal saline) will be placed either in the preoperative holding area, or in the 
operating room, with timing based on maximizing operating room efficiency.  Timing of block placement will not be 
randomized.  The regional anesthesia team will be responsible for all block and sham block placement.  To ensure 
blind integrity, study drug syringes will be marked only “study drug” and subject number.  If the anesthesia team 
suspects local anesthetic toxicity, the regional anesthesia team will break the blind and be asked to assist with 
evaluation and treatment.  
 
5.2 
Multimodal Analgesia and Perioperative Protocol 
 
In order to minimize treatment variability, the perioperative analgesic regimen will be encouraged, but not 
mandated for research subjects at the discretion of the anesthesia and surgical teams. Gabapentin 300mg, 
celecoxib 200mg, and acetaminophen 1000mg will be administered to all patients following arrival to the 
preoperative holding area.  If the patient is allergic to celecoxib or sulfa, naproxen 500mg PO will be substituted. If 
the patient is intolerant to NSAIDs or has a GFR <60 (not including GI upset for celecoxib), celecoxib/naproxen will 
be held.  If the patient is >65 years old but has a GFR >60 celecoxib/naproxen will not be held, but a reduced dose 
of celecoxib 100mg or naproxen 250mg will be administered.  If the patient is over 65 years old or has a GFR <60 
gabapentin will be held. Subjects already taking acetaminophen, gabapentin or celecoxib on a routine basis prior to 
study participation may take the pre-study home medication dosage, or the per protocol  dosage, whichever is 
higher. If a patient is intolerant to the higher protocol  dosage, the lower home dosage will be used. Other home 
medications will not be altered as a result of study participation. Standard of care block and pre anesthetic sedation 
will be at the discretion of the regional and general anesthesiology teams.   
 
Standard of care general anesthesia will be administered to all patients at the discretion of the attending 
anesthesiologist and nurse anesthetist. This is performed for all patients regardless of enrollment in the study. 
Intraoperative opioid medication will be limited to fentanyl unless the patient is intolerant to fentanyl. In that case, 
it will be at the discretion of the anesthesiologist. Fentanyl is the standard of care intraoperative pain medication 
for all surgeries at BJH and is administered to over 95% of patients.  All patients will receive the same postoperative 
order set for the PACU and hospital floor. The PACU postop order set consists of fentanyl followed by oxycodone as 
needed for patients with anticipated same day discharge to home. If the patient is scheduled for hospital admission 
following surgery, hydromorphone may also be administered following fentanyl administration. This is the most 
commonly used opioid pain medication regimen at BJH.  Patients will receive a standard antiemetic regimen 
including scopolamine patch preoperatively (if age < 65 and no history of glaucoma), 4mg IV ondansetron 
intraoperatively, 8 mg dexamethasone IV after induction of general anesthesia as needed, and postoperative orders 
for an additional dose of ondansetron as needed.  Further antiemetics will be given at the discretion of the 
anesthesiologist.   
 
Following surgery, patients will receive oral acetaminophen 1000mg Q6 hours and celecoxib 200mg BID for the first 
3 days as needed. Gabapentin 300mg will be administered at bedtime while hospitalized if the patient is not 
discharged on the same day as surgery. Home oxycodone will be prescribed per the discretion of the surgical 
attending who will also be blinded to group assignment. If the patient is intolerant to oxycodone, 
hydrocodone/acetaminophen may be substituted and scheduled acetaminophen will be held. After the first three 
days, adjuvant doses will be decreased to acetaminophen 1000mg Q8 hours and celecoxib 100mg BID as needed.  
This dosage will continue until the first postoperative visit (2 weeks postoperatively) as long as the patient is 
experiencing pain. Gabapentin will not be prescribed for any patient with preexisting kidney disease (GFR < 60) or 
with age > 65 years. Celecoxib will be administered at a reduced dose (100mg) for any patient with age > 65 and a 
normal GFR (>60) as long as the patient is experiencing pain. Naproxen 500mg or 250mg (age >65) BID will be 
substituted for celecoxib in patients with sulfa allergies. Naproxen will be held for any patient with history of NSAID 


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intolerance. Postoperative prescriptions may be modified to account for comorbidities instead of excluding patients 
from the study in order to reflect real world practice. Patients who are not able to take gabapentin, 
acetaminophen, dexamethasone, ondansetron, celecoxib, or scopolamine will not be prescribed these medications, 
but may still participate in the study. Medications and dosages may be modified by the surgeon or blinded acute 
pain service as necessary to treat the patient’s pain if the patient is intolerant to any study medications, has 
preexisting chronic pain, or if the surgeon or blinded acute pain service determines that modified medications and 
dosages is the best treatment for the patients’ pain.   
 
5.3 
Evaluability 
 
Follow up data collected for subjects that undergo additional breast surgery (exception would be minor surgery to 
breast but not axilla such as simple tissue expander replacement or lumpectomy) before 6 month and 1-year 
follow-ups, will not be considered as evaluable and will be excluded from analysis. These subjects will be 
considered as withdrawals prior to study completion at 12 months. Only data collected prior to the additional 
breast surgery is considered evaluable. Additional patients will be recruited in order to accrue the targeted number 
of complete and evaluable study subjects before the enrollment period ends.  A complete dataset requires 
collection of surveys through-out the study period of approximately 1 year. 
 
5.4 
Duration of Follow-Up 
 
Patients will be followed for one year after surgery or until an additional major breast surgery is performed, 
whichever occurs first. 
 
 
5.5 
Risks 
 
The risks associated with this study are low. PECS blocks have been performed on many patients in previous studies 
with no major complications.  The blocks have also been performed on over one hundred patients for breast and 
other procedures at BJH with no major complications.  The regional anesthesia service at Barnes Jewish Hospital 
performs over 3000 peripheral nerve blocks a year with no known recent major complications.  Since the target 
structures are fascial planes and not discrete nerves the possibility of nerve damage from the blocks is very low.  
Local anesthetic toxicity risk is also likely very low from PECS blocks due to stringent weight based dosing and 
ultrasound monitoring of block placement.  Hematoma is possible any time a needle is used to inject a patient, but 
as the breast is a compressible site a hematoma would be readily apparent and easily treated.  We follow very 
conservative ASRA guidelines for anticoagulants with regard to placement of nerve blocks which further decreases 
the chance of hematoma.  Unlike other regional anesthetics such as epidural block, a hematoma at the PECS block 
site would be unlikely to cause any lasting harm.  Infection is another risk frequently cited for regional anesthesia. 
The procedure will be performed by board-certified, trained anesthesiologist with extensive experience in using 
strict sterile technique. To date, there have been no reports of infection from a single shot peripheral nerve block 
performed at Barnes-Jewish Hospital by the regional anesthesia team.  As part of the informed consent process for 
this study, patients will be informed of the rare risks of hematoma, infection, or drug reaction. In the unlikely event 
that serious side effects occur, they will be documented and will be reported to the human research protection 
ofﬁce and to the study’s data safety monitoring board. Participants will not be ﬁnancially compensated for their 
participation.  The patients’ insurance will be billed for PECS blocks if performed as they are a standard procedure 
for prevention and treatment of acute pain.  Those that choose not to participate will receive standard treatment 
per surgeon discretion.  There is also a rare risk of breach of confidentiality.   
 
6 
REGULATORY AND REPORTING REQUIREMENTS 
 
The entities providing oversight of safety and compliance with the protocol require reporting as outline below. 
 


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The Washington University Human Research Protection Office (HRPO) requires that all events meeting the definition 
of unanticipated problem or serious noncompliance be reported as outlined in Section 6.2. 
 
6.1 
Definitions 
 
6.1.1 
Adverse Events (AEs) 
 
Definition: any unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or 
disease. 
 
Grading: the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse 
Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.  A copy of the CTCAE version 4.0 can be 
downloaded from the CTEP website. 
 
Attribution (relatedness), Expectedness, and Seriousness: the definitions for the terms listed that should be used 
are those provided by the Department of Health and Human Services’ Office for Human Research Protections 
(OHRP).  A copy of this guidance can be found on OHRP’s website: 
http://www.hhs.gov/ohrp/policy/advevntguid.html 
 
6.1.2 
Serious Adverse Event (SAE) 
 
Definition:  any adverse drug experience occurring at any dose that results in any of the following outcomes: 
o 
Death 
o 
A life-threatening adverse drug experience 
o 
Inpatient hospitalization or prolongation of existing hospitalization 
o 
A persistent or significant disability/incapacity (i.e., a substantial disruption of a person’s ability to conduct 
normal life functions) 
o 
A congenital anomaly/birth defect 
o 
Any other experience which, based upon appropriate medical judgment, may jeopardize the subject and 
may require medical or surgical intervention to prevent one of the outcomes listed above 
 
6.1.3 
Unexpected Adverse Experience 
 
Definition: any adverse drug experience, the specificity or severity of which is not consistent with the current 
investigator brochure (or risk information, if an IB is not required or available). 
 
6.1.4 
Life-Threatening Adverse Experience  
 
Definition: any adverse drug experience that places the subject (in the view of the investigator) at immediate risk of 
death from the reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more severe 
form, might have caused death. 
 
6.1.5 
Unanticipated Problems 
 
Definition: 
 
• 
unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described 
in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; 
and (b) the characteristics of the subject population being studied; 


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• 
related or possibly related to participation in the research (“possibly related” means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in the 
research); and 
• 
suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
6.1.6 
Noncompliance 
 
Definition: failure to follow any applicable regulation or institutional policies that govern human subjects research 
or failure to follow the determinations of the IRB.  Noncompliance may occur due to lack of knowledge or due to 
deliberate choice to ignore regulations, institutional policies, or determinations of the IRB. 
 
6.1.7 
Serious Noncompliance 
 
Definition: noncompliance that materially increases risks, that results in substantial harm to subjects or others, or 
that materially compromises the rights or welfare of participants. 
 
6.1.8 
Protocol Exceptions 
 
Definition: A planned deviation from the approved protocol that are under the research team’s control. Exceptions 
apply only to a single participant or a singular situation. 
 
Pre-approval of all protocol exceptions must be obtained prior to the event.  
 
6.1.9  Anticipated Adverse Events 
 
These are anticipated, study-related AE/SAEs and will be tracked and reported annually.  Refer to section 6.1.5 for 
unanticipated AE/SAE. 
 
PECS Block: 
Likely / Common 
Mild 
• 
Slight bleeding at the injection site 
Less Likely / Less Common 
Mild 
• 
Small pool of blood forming around the injection site 
• 
Bruising 
Rare   
Life Threatening 
• 
Toxic reaction to the numbing agent causing heart attack 
Serious 
• 
Nerve damage 
• 
Infection at the injection site 
 
Ondansetron: 
Likely / Common  
Mild 
• 
Constipation 
• 
Headache 
• 
Dry mouth 


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• 
Tiredness 
Less Likely / Less Common 
Mild 
• 
Diarrhea 
• 
Elevated liver function tests, which means the liver may not be functioning properly and can cause fatigue 
and jaundice (yellowing of the skin and eyes) 
Rare   
Serious 
• 
Serious irregular heartbeats 
• 
Low potassium in the blood, which can increase the risk of irregular heartbeats 
• 
Fever 
• 
Severe allergic reaction, such as rash, hives, fever, difficulty breathing, and low blood pressure 
• 
Seizures 
• 
Temporary blindness 
 
 
Gabapentin: 
Likely / Common  
Mild 
• 
Dizziness  
• 
Drowsiness  
• 
Fatigue  
 
Less Likely / Less Common 
Serious 
• 
Ataxia  
Rare   
Life Threatening 
• 
Rhabdomyolysis, which is a rapid breakdown of muscle tissue causing weakness, pain, and vomiting. 
• 
Suicidal thoughts or behavior  
• 
Drug reaction that can cause whole body inflammation which may damage organs.  
 
Celocoxib: 
Likely / Common  
Mild 
• 
Headache  
Less Likely / Less Common 
Mild 
• 
Fever  
• 
Upset stomach 
• 
Joint pain 
• 
Cough 
• 
Vomiting  
• 
Diarrhea  
• 
Gastroesophageal reflux which causes indigestion and a burning sensation in your chest and throat 
• 
Sinusitis, an infection of the spaces in the bones of your cheeks and forehead that cause pain and 
sometimes mucus drainage at the back of your throat. 
• 
Abdominal pain  
Rare  
Serious 


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• 
Elevated liver function tests, which means the liver may not be functioning properly and can cause fatigue 
and jaundice (yellowing of the skin and eyes) 
• 
Anemia 
• 
Serious rashes: called erythema multiforme or exfoliative dermatitis.  Both are severe rashes that can occur 
as an allergic response to a medication.   
 
Life Threatening 
• 
Stevens-Johnson syndrome is a severe skin condition in which the layers of your skin separate because cells 
between them die as a reaction to a drug. 
 
Acetaminophen: 
Likely / Common  
• 
None 
Less Likely / Less Common 
Mild 
• 
Rash 
• 
Disorientation 
• 
Dizziness 
Rare   
Life threatening 
• 
Liver Disease 
• 
Stevens-Johnson syndrome is a severe skin condition in which the layers of your skin separate because cells 
between them die as a reaction to a drug.  
• 
Toxic epidermal necrolysis is a severe skin condition in which the layers of your skin separate because cells 
between them die as a reaction to a drug. 
• 
Throat swelling 
• 
Agranulocytosis – Failure to produce white blood cells, which means your body would not be able to fight 
off an infection. 
• 
Thrombocytopenia – Decreased clotting cells 
• 
Kidney Disease 
• 
Pneumonia 
 
Hydromorphone/fentanyl/oxycodone/hydrocodone: 
Likely / Common  
Mild 
• 
Urinary retention  
• 
Sedation 
• 
Nausea  
• 
Constipation  
• 
Dry mouth 
• 
Dizziness  
• 
Agitation 
• 
Euphoria 
Less Likely / Less Common 
Serious 
• 
Rapid heart rate 
• 
Dysphoria, a feeling of uneasiness or agitation.  
• 
Syncope, fainting due to a sudden drop in blood pressure.   
• 
Slow heart rate 
• 
Slowing of your breathing rate 


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• 
Depression 
• 
Visual disturbances 
• 
Weakness  
Rare   
Life threatening 
• 
Coma 
• 
Seizures  
• 
Cardiac arrest or arrhythmia 
• 
Shock 
 
Scopolamine: 
Likely / Common  
Mild 
• 
Dry mouth  
• 
Drowsiness 
• 
Dilation of pupil if drug contacts eye 
• 
Dizziness  
• 
Blurred vision 
Less Likely / Less Common 
Serious 
• 
Disorientation 
• 
Confusion 
Rare   
Serious 
• 
Glaucoma, which is increased pressure inside your eyeball  
 
Dexamethasone single dosage: 
Likely / Common  
Mild 
• 
Temporary increased blood sugar 
• 
 Euphoria 
Less Likely / Less Common 
Mild 
• 
Perianal itching 
• 
Insomnia 
• 
Sweating 
• 
Rash  
Rare   
Serious 
• 
Muscle pain 
• 
Dysfunction of the adrenal gland, which fights infections 
• 
Glaucoma, which is increased pressure inside your eyeball  
• 
Hepatomegaly, an increase in the size of your liver  
• 
Hypokalemic alkalosis: A serious change in blood chemistry 
• 
Increased pressure in your head causing severe headache 
• 
Increased transaminases: Liver dysfunction of unknown significance 
• 
Psychosis, an impaired mental state where an individual has lost contact with reality. 
• 
Fluid in your lungs 
• 
Seizure 
 


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Naproxen: 
Likely / Common  
• 
None 
Less Likely / Less Common 
Mild 
• 
Abdominal pain  
• 
Constipation  
• 
Dizziness  
• 
Drowsiness  
• 
Headache  
• 
Heartburn  
• 
Nausea  
• 
Swelling 
 
Rare   
Serious 
• 
Bleeding that occurs in your stomach and/or intestines  
• 
Inflammation of small pockets in your bowels.   
• 
Difficulty breathing 
• 
Hearing disturbances  
• 
Elevated liver function tests, which means the liver may not be functioning properly and can cause fatigue 
and jaundice (yellowing of the skin and eyes) 
 
6.2 
Reporting to the Human Research Protection Office (HRPO) at Washington University 
 
The PI is required to promptly notify the IRB of the following events: 
 
• 
Any unanticipated problems involving risks to participants or others which occur at WU, any BJH or SLCH 
institution, or that impacts participants or the conduct of the study. 
• 
Noncompliance with federal regulations or the requirements or determinations of the IRB. 
• 
Receipt of new information that may impact the willingness of participants to participate or continue 
participation in the research study. 
 
These events must be reported to the IRB within 10 working days of the occurrence of the event or notification to 
the PI of the event.  The death of a research participant that qualifies as a reportable event should be reported 
within 1 working day of the occurrence of the event or notification to the PI of the event. 
 
6.3 
Reporting to the Quality Assurance and Safety Monitoring Committee (QASMC) at Washington University 
 
The PI is required to notify the QASMC of any unanticipated problem occurring at WU or any BJH or SLCH institution 
that has been reported to and acknowledged by HRPO as reportable.  (Unanticipated problems reported to HRPO 
and withdrawn during the review process need not be reported to QASMC.) 
 
QASMC must be notified within 10 days of receipt of IRB acknowledgment via email to a QASMC auditor. 
 
6.4 
Timeframe for Reporting Required Events  
 
Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later.  
Most patients will be discharged within 24 hours.  For the purposes of this protocol, adverse events thought to be 
at least possibly related to surgery will not be collected and documented on CRFs. 


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7 
PHARMACEUTICAL INFORMATION 
 
7.1 
Bupivacaine HCl 
 
7.1.1 
Bupivacaine HCl Description 
 
Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl-N-(2,6-dimethylphenyl)-, monohydrochloride, 
monohydrate, a white crystalline powder that is freely soluble in 95% ethanol, soluble in water, and slightly soluble 
in chloroform or acetone.  It has the following structural formula: 
 
 
 
 
 
Bupivacaine HCl is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and 
oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. 
 
7.1.2 
Clinical Pharmacology 
 
Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the 
threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing 
the rate of rise of the action potential. 
 
7.1.3 
Pharmacokinetics and Drug Metabolism 
 
The rate of systemic absorption of local anesthetics is dependent upon the total dose and concentration of drug 
administered, the route of administration, the vascularity of the administration site, and the presence or absence of 
epinephrine in the anesthetic solution.   
 
The onset of action with bupivacaine HCl is rapid and anesthesia is long lasting.  It has also been noted that there is 
a period of analgesia that persists after the return of sensation, during which time the need for strong analgesics is 
reduced. 
 
PK studies on the plasma profile of bupivacaine HCl after direct IV injection suggest a three-compartment open 
model.  The first compartment is represented by the rapid intravascular distribution of the drug.  The second 
compartment represents the equilibration of the drug throughout the highly perfused organs such as the brain, 
myocardium, lungs, kidneys, and liver.  The third compartment represents an equilibration of the drug with poorly 
perfused tissues, such as muscle and fat.  The elimination of drug from tissue distribution depends largely upon the 
ability of binding sites in the circulation to carry it to the liver where it is metabolized. 
 
After injection of bupivacaine HCl for caudal, epidural, or peripheral nerve block in main, peak levels of bupivacaine 
in the blood are reached in 30 to 45 minutes, followed by a decline to insignificant levels during the next three to 
six hours. 
 
7.1.4 
Supplier: Bupivacaine HCl is commercially available. 
 


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7.1.5 
Storage and Stability: Store at 20 to 25°C (68 to 77°F). 
 
7.1.6 
Administration: As described in Section 5.1. 
 
7.1.7 
Special Handling Instructions:  None. 
 
 
8 
DATA COLLECTION 
 
Baseline data will be collected during the CPAP visit, including demographics, age, radiation and chemotherapy 
history, a modified Brief Pain Inventory (Appendix A), Pain Scale (Appendix C), pain medication history, history of 
other sources of pain, and medical history (anxiety, depression, fibromyalgia).  The modified brief pain inventory 
will be administered following surgery at approximately 2 weeks, 6 months, and 12 months postoperatively in 
coordination with routine follow up visits to the surgeon’s clinic. In the event that a survey is missed a backup 
survey will be administered by email followed by mail and phone.  The Hospital Consumer Assessment of 
Healthcare Providers and Systems (HCAHPS) pain domain questions will be added to the modified BPI and analyzed 
separately (Appendix B).  The staff administering the survey will be blinded to the patient’s group.  As part of the 
SATISFY SOS study, which tracks long term postoperative outcomes, patients complete a 30-day and 1-year 
postoperative survey that includes the Veterans Rand 12 Item Health Survey (VR12) and the Barthel index, 
validated measures of quality of life and ability to perform activities of daily living.  Additional data collection will 
include surgical procedure, medications, treatments, vital signs and any adverse events or serious adverse events 
that may occur in the preoperative holding area, operating room, postoperative care unit, and medical floor 
throughout the initial hospital stay after the surgery.  Some of this data may be utilized for substudy analyses.  
Electronic medical record data will be extracted after completion of the primary intervention and subject’s 
discharge from the hospital.   
 
 
 
9 
STUDY CALENDAR 
 
 
Screening 
Baseline 
Day of 
Surgery 
72 hours 
Post-Op 
2 Weeks 
Post-Op 
30 
Days 
Post-
Op 
6 Months 
Post-Op 
1 Year 
Post-Op 
Informed consent 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
Concomitant Pain 
Medications 
X 
X 
X 
X 
X 
 
X 
X 
Randomization 
 
 
X 
 
 
 
 
 
PECS block / placebo 
 
 
X 
 
 
 
 
 
Multimodal analgesia 
 
 
As per routine care 
 
 
 
 
Modified BPI w/HCAHPS 
 
X 
 
 
X 
 
X 
X 
Pain Scale 
 
X 
 
 
 
 
 
 
VR12 
 
S-SOS 
 
 
 
S-SOS 
 
S-SOS 
Barthel Index 
 
S-SOS 
 
 
 
S-SOS 
 
S-SOS 
AE assessment 
 
 
X 
X 
X 
 
 
 
 
 
 
 


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10 
DATA SUBMISSION SCHEDULE 
 
Case report forms with appropriate source documentation will be completed according to the schedule listed in this 
section. 
 
Case Report Form 
Submission Schedule 
Original Consent Form 
Prior to registration 
Demographics 
Cancer Treatment History 
Pain Medication History 
Medical History 
Prior to starting treatment 
Randomization 
Surgery 
Day of surgery 
Modified BPI w/HCAHPS  
Baseline 
2 weeks post-op 
6 months post-op 
1 year post-op 
Pain Scale 
Baseline 
VR12 
Barthel Index 
Baseline (S-SOS) 
30 days post-op (S-SOS) 
1 year post-op (S-SOS) 
Concomitant Medications 
(Pain) 
Baseline as reported by patient 
Inpatient 
2 weeks post-op as reported by patient 
6 months post-op as reported by patient 
1 year post-op as reported by patient 
Adverse Events 
Throughout hospitalization and up to 2 weeks post-op 
 
 
 


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11 
OUTCOME MEASURES 
 
11.1 
Severity of postoperative pain 
 
Pain is inherently subjective and only quantifiable by the person experiencing the pain.  By focusing patients’ 
perception of their pain and its effects on their life with a validated survey, this design most closely mirrors how 
outcomes are assessed by CMS and what is most important to patients themselves.  The Brief Pain Inventory (BPI) is 
a validated assessment routinely used for measuring chronic pain and recommended by the Initiative on Methods, 
Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus statement. (12)  The BPI is split into two 
domains that assess the pain directly, and its interference with the patient’s life.  This allows a more complete 
characterization of the pain than a simple VAS score.  Since the BPI is designed to assess pain in the past 24 hours, 
but most persistent postoperative pain studies in breast cancer consider pain over the past 7 days significant, we 
have modified the BPI for a 7 day benchmark. (Appendix A and B) We have also modified the language to focus on 
surgical site pain, neglecting pain from other areas of the body. (Appendix B) The one year BPI severity score will be 
the primary outcome because it is likely that the one year endpoint will be least confounded by chemotherapy or 
radiation administration.   
 
At the same time as the BPI is administered additional questions from the HCAHPS survey will be asked.  These 
questions are used by the federal government to compare hospital quality, and are published online as part of 
Hospital Compare on medicare.gov.  The HCAHPS scores are also used to adjust payment to hospitals.  The two 
questions directly related to pain on the survey will be asked in order to assess if PECS blocks are associated with 
improvement in outcomes that CMS is directly measuring.   
 
11.2 
Quality of life 
 
Gross level of pain or pain scores are not necessarily the only relevant measure of pain for surgical patients.  It is 
more important to both the patient and payers if pain affects the patient’s quality of life.  Quality of life will be 
assessed based on the Veterans’ Rand 12 questionnaire collected as part of the SATISFY-SOS study.   
 
 
12 
DATA AND SAFETY MONITORING 
 
In compliance with the Washington University Institutional Data and Safety Monitoring Plan, an independent Data 
and Safety Monitoring Committee (DSMC) will be specifically convened for this trial to review toxicity data at least 
every 6 months.  A DSMC will consist of no fewer than 3 members including 2 clinical investigators and a 
biostatistician.  Like investigators, DSMC members are subject to the Washington University School of Medicine 
policies regarding standards of conduct. Individuals invited to serve on the DSMC will disclose any potential 
conflicts of interest to the trial principal investigator and/or appropriate university officials, in accordance with 
institution policies. Potential conflicts that develop during a trial or a member’s tenure on a DSMC must also be 
disclosed.  
 
The DSM report will be prepared by the study statistician with assistance from the study team, will be reviewed by 
the DSMC, and will be submitted to the Quality Assurance and Safety Monitoring Committee (QASMC).  This report 
will include: 
 
•         HRPO protocol number, protocol title, Principal Investigator name, data coordinator name, regulatory 
coordinator name, and statistician 
•         Date of initial HRPO approval, date of most recent consent HRPO approval/revision, date of HRPO expiration, 
date of most recent QA audit, study status, and phase of study 


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•         History of study including summary of substantive amendments; summary of accrual suspensions including 
start/stop dates and reason; and summary of protocol exceptions, error, or breach of confidentiality including 
start/stop dates and reason 
•         Study-wide target accrual and study-wide actual accrual  
•         Protocol activation date  
•         Average rate of accrual observed in year 1, year 2, and subsequent years  
•         Expected accrual end date, and accrual by cohort 
•         Objectives of protocol with supporting data and list the number of participants who have met each objective 
•         Measures of efficacy 
•         Early stopping rules with supporting data and list the number of participants who have met the early stopping 
rules 
•         Summary of toxicities separated by cohorts  
•         Abstract submissions/publications 
•         Summary of any recent literature that may affect the safety or ethics of the study 
 
The study principal investigator and coordinator will monitor for serious toxicities on an ongoing basis. Once the 
principal investigator or coordinator becomes aware of an adverse event, the AE will be reported to the HRPO and 
QASMC according to institutional guidelines (please refer to Section 6.0). 
 
13 
STATISTICAL CONSIDERATIONS 
 
13.1 
Statistical Analysis and Power 
 
BPI scores will be compared between groups by Mann Whitney U and adjusted for known confounders and 
baseline pain by rank ANCOVA regression.  HCAHPS pain domain scores will be analyzed similarly.  Change in the 1 
year VR12 score from baseline results will be compared between study groups by Mann Whitney U and adjusted for 
known confounders using ANCOVA regression analysis.  For the purpose of powering the study a decrease in 
Modified BPI score (average severity domain, 0-10) of 50% (3  1.5) will be considered clinically significant.  A 
sample size of 64 patients per group will have 80 percent power to detect this difference with an alpha level of 0.05 
assuming a standard deviation of 3 points and using two tailed Student’s T test.  Our target sample size is increased 
to 80 patients per group to account for dropout and possible confounders including surgery type, age, radiation 
history, chronic pain history, and ASA score.  By using rank ANCOVA regression analysis (Quade’s test) we hope to 
decrease the within group error variance and minimize the impact of these confounders.  Our goal of a 50% 
reduction in score is realistic for a pilot study given that previous studies with paravertebral nerve block are 
associated with reductions in PPP of up to 86%. (8)   
 
13.2 
Limitations 
 
We recognize these analyses rely on subjective patient reporting of pain scores and pain’s effects on quality of life.  
We do not intend to verify this with objective examinations of pain and decreased range of motion of the affected 
extremity because it is the subjective outcomes that are of importance to patients.  Our sample size is powered to 
look for a 50% reduction of PPP by BPI average severity domain score.  While this is relatively aggressive, our 
projected sample size of 80 patients per group is double previous studies examining paravertebral nerve block’s 
benefits on persistent postoperative pain. (13, 8,9) Since we are powered for an outcome larger than would be 
clinically relevant (50% vs 20% decrease in PPP) this could be considered a pilot study if we achieve a clinically 
significant but not statistically significant outcome.   
 
 


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14 
References 
 
1) American Cancer Society: Cancer Facts and Figures 2016. Atlanta, Ga: American Cancer Society, 
2016. http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-047079.pdf Last 
accessed February 1, 2016. 
2) Siegel R, DeSantis C, Virgo K, et al. Cancer treatment and survivorship statistics, 2012. CA Cancer J Clin. Jul-Aug 
2012;62(4):220-41. 
3) Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and 
strategies for prevention. J Pain2011;12:725-46. 
4) Gärtner R, Jensen M-B, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with 
persistent pain following breast cancer surgery. JAMA. 2009; 302: 1985–1992. Serial Solutions Bibliographic 
5) National Cancer Institute SEER Stat Fact Sheets: Female Breast Cancer 
http://seer.cancer.gov/statfacts/html/breast.html Last accesed February 17, 2016 
6) Darrell J. Gaskin, Patrick Richard. The Economic Costs of Pain in the United States. The Journal of Pain, 2012; 13 
(8): 715 
7) Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic 
review and meta-analysis. Br J Anaesth. 2013;111:711–20. 
8) Kairaluoma PM, Bachmann MS, Rosenberg PH, Pere PJ. Preincisional paravertebral block reduces prevalence of 
chronic pain after breast surgery. Anesth Analg. 2006;103:703–8.  
9) Ibarra MM, S-Carralero GC, Vicente GU, Cuartero del Pozo A, Lopez Rincon R, Fajardo del Castillo MJ. Chronic 
postoperative pain after general anesthesia with or without a single-dose preincisional paravertebral nerve block in 
radical breast cancer surgery (in Spanish). Rev Espanola Anestesiol Reanimacion. 2011;58:290–4. 
10) Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 
29.Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery.Blanco R1, Fajardo M, 
Parras Maldonado T. 
11) Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163. Pectoral nerves I and II 
blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Bashandy GM1, Abbas DN.  
12) Dworkin RH, Turk DC, Peirce-Sandner S, et al. Research design considerations for conﬁrmatory chronic pain 
clinical trials: IMMPACT recommendations. Pain. 2010;149:177–93.  
13) Ilfeld BM1, Madison SJ, Suresh PJ, Sandhu NS, Kormylo NJ, Malhotra N, Loland VJ, Wallace MS, Mascha EJ, Xu 
Z, Wen CH, Morgan AC, Wallace AM. Persistent postmastectomy pain and pain-
related physical and emotional functioningwith and without a continuous paravertebral nerve block: 
a prospective 1-year follow-upassessment of a randomized, triple-masked, placebo-controlled study. Ann Surg 
Oncol. 2015;22(6):2017-25. 
 


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Appendix A: Modified BPI Baseline 
 
1. Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and 
toothaches). Have you had pain other than these everyday kinds of pain during the last week? 
 
 
Yes 
 
No 
2. On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most. 
 
3. Please rate your pain by circling the one number that best describes your pain at its worst in the past week     
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
3. Please rate your pain by circling the one number that best describes your pain at its least in the last week.   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
 


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4. Please rate your pain by circling the one number that best describes your pain on the average.   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
5. Please rate your pain by circling the one number that tells how much pain you have right now.   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
6.What treatments or medications are you receiving for your pain (including over the counter and prescription 
medications)?  
 
_______________________________________________________________________________________   
 
7. Are you using any narcotic prescription medications such as Hydrocodone, Morphine, or Oxycodone? 
 
    
   
  Yes   
  
  No       
 
 
8. In the last week, how much relief have pain treatments or medications provided? Please circle the one 
percentage that most shows how much relief you have received.   
     0%  10% 
 20% 
 30% 
 40% 
 50% 
 60% 
70%    80%      90%     100%   
    
      
        
        
        
        
       
       
      
         
        
         
No relief 
 
 
 
 
 
 
 
           Complete relief  
 
9. Circle the one number that describes how much, during the past week pain has interfered with your:   
A. General Activity   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes 
 
 
 
 
 
 
 
  
B. Mood   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
 
 
C. Walking Ability   


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     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
D. Normal Work (includes both work outside the home and housework)   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
E. Relations with other people   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
F. Sleep   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
G. Enjoyment of life   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
 


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Modified BPI with HCAHPS follow-up survey 
 
 
PECS study – Guffey PI 
 
1. Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and 
toothaches). Have you had pain other than these everyday kinds of pain during the last week? 
 
 
 Yes  
 No 
 
2. On the diagram, shade in the areas where you feel pain. Put an X on the area that hurts the most. 
 
 
2. Is your pain worst in the: 
 
    
  Breast 
 
 
  Armpit 
 
 
  Neither 
 
 
3. Please rate your pain from your breast or armpit surgery by circling the one number that best describes your pain 
at its worst in the last week.   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
 


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4. Please rate your pain from your breast or armpit surgery by circling the one number that best describes your pain 
at its least in the last week.   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
5. Please rate your pain from your breast or armpit surgery by circling the one number that best describes your pain 
on the average.   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
6. Please rate your pain from your breast or armpit surgery by circling the one number that tells how much pain you 
have right now.   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
No Pain  
 
 
 
 
 
 
 
 
Pain as bad  
as you can imagine 
 
7.What treatments or medications are you receiving for your pain?  
 
_________________________________________________________________   
 
8. Are you using any narcotic prescription medications such as Hydrocodone, Morphine, or Oxycodone? 
 
    
   
  Yes   
  
  No       
 
 
9. In the last week, how much relief to your breast or armpit pain have pain treatments or medications provided? 
Please circle the one percentage that most shows how much relief you have received.   
     0%  10% 
 20% 
 30% 
 40% 
 50% 
 60% 
70%    80%      90%     100%   
    
      
        
        
        
        
       
       
      
         
        
         
No relief 
 
 
 
 
 
 
 
           Complete relief  
 
 
 
 
 
 
 
10. Circle the one number that describes how much, during the past week, breast or armpit pain has interfered with 
your:   
A. General Activity   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    


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Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes 
 
 
 
 
 
 
 
  
 
B. Mood   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
C. Walking Ability   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
D. Normal Work (includes both work outside the home and housework)   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
E. Relations with other people   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
F. Sleep   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
 
 
G. Enjoyment of life   
     0 
   1 
    2 
    3 
    4 
    5 
   6 
   7          8 
 9 
 10    
    
      
        
        
        
        
       
       
      
         
        
         
Does not 
 
 
 
 
 
 
 
 
Completely 
 
Interfere 
 
 
 
 
 
 
 
 
interferes  
11. During your hospital stay for your breast cancer surgery, how often was your pain well controlled?  
 
1  
  Never  
2  
  Sometimes  


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3  
  Usually  
4  
  Always   
 
 
12. During your hospital stay for your breast cancer surgery, how often did the hospital staff do everything they 
could to help you with your pain?  
 
1  
  Never  
2  
  Sometimes  
3  
  Usually  
4  
  Always   
 
13. Have you had chemotherapy in the last 6 months? 
    
   
  Yes   
  
  No       
 
14. Have you had radiation in the last 6 months? 
    
   
  Yes   
  
  No       
 
15. Have you had surgery since your recent breast cancer surgery? 
    
   
  Yes   
  
  No       
 
15b. If yes, where on your body was your surgery?    _____________________________________ 
 
16. Are you planning on having surgery in the next year? 
   
   
  In the next 6 months 
   
  Between 6 months and 1 year  
 
  Unknown time 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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Appendix C: Pain Scale 
 
Everyone experiences painful situations at some point in their lives.  Such experiences may include headaches, 
tooth pain, joint or muscle pain.  People are often exposed to situations that may cause pain such as illness, injury, 
dental procedures or surgery. 
 
We are interested in the types of thoughts and feeling that you have when you are in pain.  Listed below are 
thirteen statements describing different thoughts and feelings that may be associated with pain.  Using the scale, 
please circle the degree to which you have these thoughts and feelings when you are experiencing pain. 
 
 
 
Not at all 
To a slight 
degree 
To a moderate 
degree 
To a great 
degree 
All the 
time 
When I’m in pain… 
 
 
 
 
 
 
 
 I worry all the time about whether the 
pain will end 
0 
1 
2 
3 
4 
 
I feel I can’t go on 
0 
1 
2 
3 
4 
 
It’s terrible and I think it’s never going 
to get any better 
0 
1 
2 
3 
4 
 
It’s awful and I feel that it overwhelms 
me 
0 
1 
2 
3 
4 
 
I feel I can’t stand it anymore 
0 
1 
2 
3 
4 
 
I become afraid that the pain will get 
worse 
0 
1 
2 
3 
4 
 
I keep thinking of other painful events 
0 
1 
2 
3 
4 
 
I anxiously want the pain to go away 
0 
1 
2 
3 
4 
 
I can’t seem to keep it out of my mind 
0 
1 
2 
3 
4 
 
I keep thinking about how much it 
hurts 
0 
1 
2 
3 
4 
 
I keep thinking about how badly I want 
the pain to stop 
0 
1 
2 
3 
4 
 
There’s nothing I can do to reduce the 
intensity of the pain 
0 
1 
2 
3 
4 
 
I wonder whether something serious 
may happen 
0 
1 
2 
3 
4