Regional Nerve Blocks in Alloplastic Breast Reconstructive Surgery: A Pilot, Randomized Controlled Trial
Phase: NA
Conditions: Surgery, Plastic, Mastectomy, Nerve Block, Breast Reconstruction
Sponsor: University of British Columbia

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Title of Study: Regional nerve blocks in alloplastic breast reconstructive surgery: A 
pilot, randomized controlled trial 
 
Project Nickname: Nerve blocks in alloplastic breast reconstruction 
 
Principal Investigator: 
Kathryn Isaac, MD, MPH, FRCSC 
UBC Department of Surgery, Mount Saint Joseph Hospital 
604-336-9488 
 
Co-Investigator(s):  
Rebecca Warburton, MD, FRCSC 
UBC Department of Surgery, Mount Saint Joseph Hospital 
604-977-8511 
 
Christopher Prabhakar, MD, FRCPC, CCFP 
UBC Department of Anesthesiology, Mount Saint Joseph Hospital 
604-806-8337 ext 62813 
 
Lisa Li, MD, FRCSC 
UBC Department of Anesthesiology, Mount Saint Joseph Hospital 
 
Nancy Van Laeken, MD, FRCSC 
UBC Department of Surgery, Mount Saint Joseph Hospital 
 
Esta Bovill, MD, PhD, FRCSC 
UBC Department of Surgery, Mount Saint Joseph Hospital 
 
Primary Contact: 
Caroline Illmann, MSc, Clinical Research Coordinator, UBC Division of Plastic Surgery 
 
Additional Team Members:  
Nicole Steinbrecher, BSc, BScN, UBC MD Candidate 2022 
 
Anne Nguyen, BSc, MSc, MD, Clinical Research Associate, PHC Department of Surgery 
 
Fagun Jain, MSc, Clinical Research Coordinator, UBC Division of Plastic Surgery  
 
Project Period: November 2020 – November 2021 
Source of Funding: n/a 
Conflict of Interest: none 
UBC REB: UBC-PHC CREB  
Site: PHC, Mount Saint Joseph Hospital 
Full Board Review 
Peer Review: Non-Independent Peer Review done 
Other Required Documents: See Study Forms 1-12 

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Short Summary (<100 words): (94 words) 
Pain management is a major concern in oncologic breast surgery and reconstruction. 
Significant risks for acute and chronic pain after surgery might be reduced through 
improved pain control pre-operatively. Addition of regional anesthesia to a multimodal 
peri-operative pain management protocol offers a promising solution for improved 
recovery. For patients undergoing mastectomy with immediate alloplastic breast 
reconstruction, this RCT compares Thoracic Paravertebral+Pec I local anesthetic block 
with a placebo normal saline block for their effect on acute pain, chronic pain, opioid 
consumption, opioid-related side effects, patient-reported quality of recovery after 
surgery, and length of stay. 
 
 
Table of Contents 
 
1. Introduction  
a. Background 
b. Regional blocks in breast reconstruction 
i. Pectoralis, Serratus blocks  
ii. Thoracic Paravertebral Blocks 
c. Hypothesis 
d. Objectives 
e. Significance 
2. Methods 
a. Study Design 
b. Study Setting 
c. Inclusion/Exclusion criteria 
d. Recruitment  
3. Outcome Measures 
4. Risk and Benefit estimates 
a. Assessment of Safety 
b. Adverse events 
5. Statistical Analysis  
6. Research Protocols 
7. Data Collection forms 
8. Confidentiality 
9. Timeline 
10. Appendices 
a. Appendix 1: Nerve block protocol 
b. Appendix 2: Multi-modal perioperative management protocol 
c. Appendix 3: MME equivalence 
d. Appendix 4: PACU and SDC Discharge criteria 
e. Appendix 5: Study Timeline 
 
 
 

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SECTION 1: INTRODUCTION (back) 
 
Background/Justification 
 
Breast cancer is the most commonly diagnosed cancer in females in Canada, 
making up 25% of all cancers diagnosed in this population.1 When surgical treatment 
necessitates a mastectomy, immediate breast reconstruction (IBR) is a safe option for 
patients with early stage cancer.2 Options for breast reconstruction include autologous 
tissue or alloplastic reconstruction with a prosthesis (insertion of tissue expander or 
immediate insertion of implant). In Canada, rates of IBR are increasing, with 
approximately 15-40% of breast cancer patients undergoing reconstruction in British 
Columbia.3 Alloplastic reconstruction (with tissue expanders and implants) accounts for 
the majority of reconstructions in North America and is associated with more pain than 
autologous forms of breast reconstruction.4-9   
 
Importantly, acute and chronic pain can be a major factor in patient recovery after 
breast reconstruction surgery.10 Approximately 40%-47% of patients undergoing breast 
surgery experience significant acute postoperative pain.5,11 Severe acute postoperative 
pain increases the likelihood of chronic pain in the breast and ipsilateral arm.12 Chronic 
postoperative pain, defined as pain that persists after 3-6 months after surgical 
intervention, hinders survivor recovery, reducing productivity and overall quality of 
life.13,14 One year after surgery, approximately 50% of patients who had a mastectomy 
and reconstruction experience pain compared to 30% of women who had a mastectomy 
without reconstruction.5,15-17  Recent population cohort studies report little improvement 
in the incidence of chronic post-mastectomy pain, estimating 40-50% of patients suffer 
with resultant decrease in quality of life.12,16,17  
 
Within alloplastic reconstruction, the use of tissue expanders increases the use of 
opioid and non-opioid analgesia as compared to the immediate insertion of an implant.6 
Predictive risk factors have been identified for developing chronic pain after breast 
surgery. Psychosocial and patient factors include baseline preoperative anxiety, 
depression, high BMI, younger age (<40), and catastrophizing.18,19 Surgical factors 
include severe acute post-operative pain, axillary surgery, and adjuvant radiotherapy.12,18 
These studies underscore the importance of adequate perioperative pain management to 
reduce the risk of chronic pain in the setting of specific prognostic factors and to improve 
overall recovery.   
 
Evidence-based multimodal perioperative management protocols improve the 
quality and value of care delivered for breast reconstruction patients.20-22 These Enhanced 
Recovery After Surgery (ERAS) protocols have been applied to patients undergoing 
mastectomy with immediate alloplastic breast reconstruction and successfully 
demonstrate benefits of decreased opioid usage, decreased acute post-operative pain, 
same-day discharge, patient satisfaction, and well-being.20,21,23-25 In these published 
recommendations for optimal perioperative care, regional blocks of the chest are absent 
from the list of supported strategies due to lack of high-level evidence.15,20,21,26 Recent 
systematic reviews and anesthesia guidelines support regional blocks as an important 

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adjunctive strategy to these multimodal perioperative protocols for patients undergoing 
major oncologic breast surgery and breast reconstruction.26-28   
 
Regional blocks of the chest have the potential to decrease acute and chronic pain 
but are absent from the list of supported strategies due to lack of high-level 
evidence.15,20,21,26 Recent meta-analysis, systematic reviews and anesthesia guidelines 
support regional blocks as an important adjunctive strategy to these multimodal 
perioperative protocols for patients undergoing major oncologic breast surgery and breast 
reconstruction.26-29 
 
Regional anesthesia techniques in breast cancer surgery include thoracic epidural 
blocks, thoracic paravertebral blocks (TPVB), pectoralis (pecs) blocks and serratus 
anterior (SA) plane block. According to recent procedure-specific guidelines, TPVB are 
recommended for pain management after oncologic breast surgery as part of a 
multimodal perioperative protocol.27  TPVB combined with general anesthesia (GA), as 
compared to GA alone, significantly reduce the worst postoperative pain scores in early 
postoperative period (<2h) (mean difference - 2.68; 95% CI:-3.33 to-2.02, p<0.00001).29 
While the TPVB provides superior analgesia, the pecs and SA blocks are less invasive, 
are effective adjuncts in pain management, and may have a superior safety profile.15,28,30   
 
Oncologic breast surgery with and without reconstruction differs with respect to 
the pectoralis and serratus muscles.  In alloplastic breast reconstruction, the pectoralis 
major muscle is disinserted and elevated to insert the prosthesis.  The serratus fascia may 
also be elevated to support the soft tissue coverage of the prosthesis. This surgical 
dissection of pectoralis and serratus is absent in oncologic breast surgery without 
reconstruction. Pecs I and II, SA, and TPVB are indicated for alloplastic breast 
reconstruction.26,31 The optimal regional block for alloplastic breast reconstruction is not 
known.   
 
 
Current Approaches to Regional Blocks in Oncologic Breast Surgery & Reconstruction 
 
1. Pecs Block  (back) 
 
The Pecs I block, first described by Blanco, involves injecting local anesthetic 
under ultrasound guidance into the interfascial plane between pectoralis major and 
minor.32 Pecs I block is used to anesthetise the lateral and medial pectoral nerves. Pecs II 
block, also described by Blanco, involves injecting local anesthetic under ultrasound 
guidance above the SA muscle at the level of the third rib.33 The technique includes and 
expands on the Pecs I block to target the pectoral, intercostobrachial, intercostals III-VI, 
and long thoracic nerves in addition to the lateral and medial pectoral nerves (which are 
blocked in Pecs I).15 Both the pecs I and II blocks may be done as a single injection. The 
pecs blocks are simple to perform under ultrasound guidance, do not cause any 
sympathetic blockade, and are fast-acting.15,28  
 

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Two randomized controlled trials (RCTs) evaluating combined pecs I and II block 
demonstrated a reduction of intraoperative opioid consumption (mean total fentanyl 
consumption 141 +/- 32 ug intervention versus 218 +/- 24 ug control group, p<0.001), 
postoperative opioid consumption (mean total fentanyl consumption 438 +/- 72 
intervention versus 609 +/- 53 ug control group, p<0.001), and lower pain scores for 
patients undergoing modified radical mastectomy compared to controls who received 
general anesthesia alone.34,35 Reduced postoperative nausea, vomiting, sedation scores, 
and improved early shoulder mobility have also been reported for patients undergoing a 
pecs block compared to controls.34  
 
The effect of Pecs II block in patients undergoing modified radical mastectomy 
with IBR with an implant and latissimus dorsi flap was assessed in a recent RCT.36  
Wang et al. found a significant reduction in intra- and postoperative opioid consumption, 
less postoperative nausea and vomiting, and reduced pain scores in the Pecs II with 
general anesthesia as compared to general anesthesia alone.  
 
There are few studies comparing pecs I and pecs II blocks. One study compared 
pecs I to pecs II blocks using epidural catheters placed under direct vision 
intraoperatively during modified radical mastectomy surgery, and found that pecs II 
offered superior postoperative analgesia compared to pecs I.37 There are no reported 
studies directly comparing pecs I to pecs II in breast reconstruction surgeries. 
 
An important disadvantage of the Pecs II block is the disruption of the axillary 
tissue planes which can directly affect axillary surgery.38  Furthermore, neural blockade 
of the long thoracic nerve and other axillary nerve branches with Pecs II block is 
problematic for axillary lymph node dissection when intra-operative nerve stimulation is 
used for identification and preservation.  
  
 
2. Serratus Anterior Plane Block 
 
The SA block involves ultrasound-guided injection of local anesthetic into the 
potential spaces superficial and deep to the SA muscle. It targets the thoracic intercostal 
nerves.39 The SA block developed as a method to provide complete analgesia of the 
lateral thoracic cage as an alternative to the TPVB or thoracic epidural blocks. The SA 
block may be performed as a superficial or deep block (or both). The blocks are similar in 
terms of patient-reported pain postoperatively.40,41 The superficial SA block may have 
less risk of pneumothorax, but both the superficial and deep SA blocks have a good 
safety profile.38,40,42 The deep SA block is preferred for breast cancer surgeries involving 
the axillary or sentinel lymph nodes, as the anesthetic does not infiltrate the axillary 
tissue planes, unlike the superficial SA block.40,42 The blocks are similar in their 
analgesic effect.40,42 
 
Several studies support the role of the SA block with general anesthesia compared 
to general anesthesia alone. A recent RCT found the ultrasound-guided SA block with 
general anesthesia resulted in significantly lower opioid requirements intra- and 

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postoperatively, and no differences in complication rates or postoperative nausea and 
vomiting.30 A second study comparing the deep SA block under direct visualization to 
general anesthesia alone found the SA block resulted in marginally lower pain scores, but 
notably with no reports of severe pain in the first 24 hours after surgery.43 No adverse 
events related to the blocks were observed in this study. However, these preceding 
studies included fewer than 5 patients undergoing breast reconstruction.  
 
Retrospective comparison of Pecs I, SA blocks, and controls in breast cancer 
surgery without reconstruction found that Pecs I and SA blocks each reduced 
postoperative opioid consumption and postoperative nausea and vomiting.38   
 
 
3. Thoracic Paravertebral Block  (back) 
 
TPVB targets the spinal nerves as they emerge from the intervertebral foramina.  
Under ultrasound guidance, a needle is inserted lateral to the vertebral spinous processes 
to anesthetize single or multiple spinal nerves, resulting in anesthesia the corresponding 
dermatomes. 
 
Based on multiple meta-analyses of randomized clinical trials, TPVB is 
considered to be one of the most effective blocks for long-lasting analgesia after breast 
cancer surgery.15,27,29,44,45  In oncologic breast surgery, meta-analyses of TPVB with 
general anesthesia compared to general anesthesia alone support that TPVB with general 
anesthesia resulted in superior postoperative pain control.27,29  TPVB alone has also been 
compared to general anesthesia with similar results, including lower pain scores, lower 
opioid consumption (RR 0.23, 95%CI 0.15-0.37), lower incidence of post-operative 
nausea and vomiting (RR 0.27; 95% CI 0.12-0.61), and shorter lengths of hospital stay.44 
TPVB has also been shown to reduce prevalence of chronic pain at one year following 
mastectomy with or without axillary surgery.46    
 
For patients undergoing alloplastic IBR, observational studies support the use of 
TPVB compared to general anesthesia alone for reduction in LOS, opioid consumption,  
post-operative pain scores, and post-operative nausea and vomiting.47-50 A single RCT in 
the setting of alloplastic reconstruction compared PVB with general anesthesia to general 
anesthesia alone.51  In this non-blinded, non-placebo controlled RCT, the TPVB 
intervention resulted in a significant reduction in acute pain scores, total opioid 
administered, and total anti-emetics consumed. Patient-reported satisfaction and nausea 
and vomiting did not differ significantly between groups. This trial’s study population 
was a heterogenous group that included reconstructive procedures without mastectomy or 
axillary surgery, did not blind exposure or outcome measures, and lacked a placebo 
control. Further high-level evidence and study is required to establish the value of TPVB 
in immediate alloplastic breast reconstruction.  
 
Overall, ultrasound-guided TVPB is a safe approach with a complication rate of 
0.70%.52   Adverse events from the TPVB have been reported in meta-analyses of 
randomized clinical trials. Pooled analysis from 11 trials published 1999-2009 (reported 

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for 771 patients) revealed a very low relative risk of: Horner’s syndrome (RR 0.05, CI 
0.02 – 0.09), pneumothorax (RR 0.01, CI 0.02 – 0.03) post-operative nausea and 
vomiting (RR 0.26, CI 0.13 – 0.5), nerve damage (n=0), and vascular injury (n=0).29  
Failed anesthetic technique was the most common adverse event reported with a relative 
risk of 4.34 (CI 0.74 - 25.24).  
 
Disadvantages of the TPVB includes poor anesthesia of the medial anterior chest 
and operator dependence, potentially influencing the efficacy and safety of the block.  
 
 
Selecting the optimal regional block for Alloplastic Breast Reconstruction  
 
There is growing evidence to support the addition of pecs I and SA blocks for 
mastectomy (with or without axillary surgery) with IBR using tissue expanders or 
immediate implants. Early case reports and subsequent series in breast surgery with and 
without reconstruction supported the combination of Pecs I and SA blocks resulting in 
lower opioid consumption.53-56 A single RCT of combined Pecs I and SA blocks for 
modified radical mastectomy with axillary lymph node dissection and IBR reported 
reduced opioid consumption and decreased postoperative pain scores.57 While promising, 
this trial did not specify the type of breast reconstruction performed.  
 
Two RCTs found the Pecs II block resulted in improved postoperative analgesia 
and reduced opioid consumption compared to TPVB.58,59 However, meta-analyses of 14 
randomized trials comparing Pecs II and TPVB concluded that Pecs II and TPVB provide 
comparable analgesic effect.60  Although Pecs II has merit, the disruption of axillary 
tissue as a result of Pecs II renders this regional block an inferior option for our surgical 
population which commonly requires sentinel lymph node biopsy or axillary dissection.38  
 
There is a paucity of high-quality studies investigating the additional benefit of 
regional blocks for immediate breast reconstruction. Given the effectiveness and safety of 
TPVB, Pecs I and SA blocks in oncologic breast surgery, we sought to investigate the 
benefit of TVPB with Pecs I block in the framework of a multimodal peri-operative 
management protocol. We have selected the most effective block in oncologic breast 
surgery, namely TPVB, and added the Pecs 1 (TPVB+) to provide the anesthesia required 
for the disruption of pectoralis muscle that occurs with immediate alloplastic breast 
reconstruction.  
 
Hypothesis  (back) 
 
Local anesthetic regional blocks (LA blocks) of the thoracic paravertebral space and the 
pectoralis major (TPVB+) will reduce chronic pain.  
 
Secondary hypotheses include: TPVB+ will decrease opioid consumption, postoperative 
nausea and vomiting, decrease patient-reported postoperative pain scores, length of stay, 
and improve patient-reported quality of recovery in patients undergoing total mastectomy 
with IBR using tissue expanders or immediate implants. 

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Objectives  (back) 
 
The primary objectives of the pilot trial are to demonstrate feasibility of recruitment and 
to demonstrate efficacy potential. The primary objectives of the definitive trial are to 
determine if Thoracic Paravertebral with Pecs 1 blocks (TPVB+) will reduce opioid 
consumption and chronic pain compared to a TPVB+ sham block in patients undergoing 
mastectomy with IBR using tissue expanders or implants.  Secondary objectives of the 
definitive trial include assessment of opioid consumption, patient-reported postoperative 
pain scores, postoperative nausea and vomiting, length of stay, and patient-reported 
quality of recovery.  
 
 
Significance  (back) 
 
The definitive trial will determine if TPVB+ improves postoperative acute and chronic 
pain and reduces opioid use for patients undergoing mastectomy with IBR using tissue 
expanders or immediate implants. 
 
International Consensus guidelines for ERAS in breast reconstruction make a strong 
recommendation for multimodal, opioid-sparing analgesia postoperatively based on high-
level evidence.22 Increased total opioid analgesic use has been shown to increase length 
of stay in hospital.25 Reduced opioid consumption results in less postoperative nausea, 
vomiting, and constipation, supports early ambulation, shortens hospital stays, and 
improves psychological well being.21 Current ERAS protocols for alloplastic breast 
reconstruction are successfully opioid-sparing and address acute recovery.21,25 However, 
opioids continue to play an important role in peri-operative protocols for achieving 
adequate pain control, which suggests further adjunctive strategies may be beneficial.  
Furthermore, the effects of peri-operative protocols on the development of chronic pain 
are lacking.  By evaluating the effectiveness of TPVB+ in alloplastic reconstruction, our 
proposed study would help to establish an important additional feature to the ERAS 
pathway for our hospital and other institutions.  
 
Furthermore, the COVID-19 pandemic has caused an unprecedented shift in pressures 
facing our healthcare system. Operating room closures and pauses in screening for certain 
conditions (eg. mammography for breast cancer) in the spring of 2020 resulted in a 
backlog of an estimated 30,298 surgical cases.61 As British Columbia enters a phase of 
surgical renewal to meet patient demand, finding ways to limit use of in-patient resources 
while providing safe surgical care remains more important than ever. In this context, the 
use of regional anesthesia such as the TPVB+ block is very timely. By enhancing 
multimodal perioperative analgesia, the TPVB+ block may reduce perioperative and 
postoperative opioid requirements, reduce patient symptoms that could delay discharge, 
and shorten overall length of hospital stay. This could maximize the efficient use of 
needed surgical resources, while preserving inpatient resources for treatment of COVID-
19 patients. 

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Benefits for Patients 
 
Patients may benefit from LA blocks (TPVB+) by requiring less total opioid analgesia in 
the perioperative period. Patients may report reduced postoperative pain scores, and may 
experience fewer side effects related to opioid consumption (nausea and vomiting). This 
may result in a shorter length of stay in hospital and improved overall quality of recovery. 
Furthermore, the reduction in acute pain may reduce the incidence of chronic pain.  
 
The use of regional anesthesia (rather than general anesthesia alone) may reduce 
recurrent breast cancer risk, although this is currently under investigation.62,63  
 
Benefits for Researchers 
 
The benefit to the plastic surgeon, general surgeon, and anesthesiologist will be 
knowledge of the patient-reported effectiveness as well as the postoperative and long-
term morbidity of LA blocks as measured by total opioid analgesia in the perioperative 
period, patient-reported postoperative pain scores, side effects related to opioid 
consumption, reported quality of recovery and incidence of chronic pain. There may be 
an additional benefit of shorter length of stay in hospital, which has positive implications 
both for patients and for improved resource allocation within the health care system.  
 
 
SECTION 2: METHODS  (back) 
 
Study Design  (back) 
 
The design of the pilot RCT is the same as the future definitive trial, a parallel-group, 
double-blinded randomized controlled trial (RCT). The target population are patients 
undergoing mastectomy with IBR using tissue expanders or immediate implants. The 
intervention will be a local anesthetic regional block defined as a TPVB with Pecs 1 
(TPVB+) using local anesthetic infiltrate. The local anesthetic block (LA block) will be 
compared to a placebo block (sham block) using normal saline infiltrate. Thus, each 
patient in this study will be assigned to receive either; 1) LA Block: TPVB and Pecs I 
block with local anesthetic infiltrate, or 2) sham block: TPVB and Pecs I block with 
saline infiltrate. The assignment of intervention will be determined by randomization 
through REDCap. The pilot trial will be conducted at Mount Saint Joseph Hospital 
(MSJH). 
 
Each participant will be assigned a consecutive Study ID at time of enrollment. Patients 
will be randomized 1:1 to either LA or sham block. Patients undergoing symmetrizing 
procedures as part of a bilateral breast surgery will not have a regional block on the 
symmetrizing side (which is not IBR). Patients undergoing bilateral IBR surgery using 
implants or expanders on both breasts will not be included in the study due to risk of 
local anesthetic toxicity with bilateral TPVB+. 
 

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The randomization sequence will be created using REDCap-generated 1:1 randomization 
with permuted blocks of varying size (4 and 6). The assignments (LA or sham) will be 
placed in order in opaque, consecutively numbered envelopes. The sequence and 
envelopes will be created by an independent research assistant who will not be involved 
in the remainder of the study implementation.  
 
Study participants, Operating Room (OR) anesthesiologists, surgeons, research assistants, 
and nurses in the OR, Post-anesthesia Care Unit (PACU), and ward will be blinded as to 
whether a participant receives LA block or sham block. At MSJH, the anesthesiologists 
in the operative theater are separate from the team of regional anesthesiologists 
performing regional blocks in the preoperative area. Only the regional anesthesiologist 
and anesthesia assistant in the preoperative block area will be unblinded to reduce the 
potential unnecessary risk of a pneumothorax with the sham saline TPVB. This will 
enable injection of saline just outside of the paravertebral space.  
 
On the day of surgery, the regional anesthesiologist at MSJH will be provided with the 
Study ID specific sealed envelope which will assign the patient to receive either the LA 
block or sham block. The regional anesthesiologist will prepare local anesthetic or 
normal saline injections for infiltration based on the random assignment. For all patients, 
the regional block will be performed as outlined in the Procedure Protocols (See 
Appendix 1: Nerve Block). The regional anesthesiologist will be unblinded and will 
therefore be able to purposefully inject the saline block in a safe plane outside of the 
paravertebral space to further reduce the risk of pneumothorax. All other parameters and 
protocols will be identical.  
 
Currently, at MSJH, approximately 4 - 5 cases of mastectomy with IBR are performed 
per week. We do not anticipate difficulty with enrolment into this study. This internal 
pilot will generate initial recruitment data to enable an early review and validation of our 
recruitment projections and study population target prior to transition to formal RCT.  
 
 
Study Setting  (back) 
 
The pilot trial will take place at MSJH in Vancouver, BC. Study enrolment and all 
subsequent study activities will take place on site at MSJH. The planned timeline for 
recruitment into the study is one year from REB approval (tentatively December 2020). 
 
 
Inclusion Criteria  (back) 
 
1- Patients must be female, and at least 19 years old. 
2- Patients must be ASA grade I or II.  
3- Patients must be undergoing total mastectomy with IBR using tissue expander or 
implant, with or without axillary surgery.  
  
 

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Exclusion Criteria  (back) 
 
Patients will be excluded if: 
1- Patients have a known contraindication for a regional block: known coagulation 
disorder, treatment with anticoagulants, infection at the injection site, known 
allergy to medication in the study.  
2- Patients who are pregnant at the time of surgery. 
3- Patients having bilateral mastectomy and immediate alloplastic breast 
reconstruction (as only one side can be blocked to prevent local anesthesia 
toxicity).  
4- Patients with ASA Class III or IV. 
5- Patients with BMI>35kg/m2. 
6- Patients weighing less than 50kg. 
7- Patients living/staying outside of 1-hour driving distance from hospital. 
 
 
Recruitment  (back) 
 
Plastic surgeons will identify potential eligible candidates for this study once they have 
consented for mastectomy with alloplastic IBR. Plastic surgeons will have adequate 
information after consultation to indicate whether the patient meets eligibility criteria.  
For potential participants who meet eligibility criteria, the plastic surgeon will introduce 
the study. The list of eligible potential participants will be emailed by the surgeon to the 
research assistant. Plastic surgeon will not be directly involved with recruitment and 
consent process. 
 
The research assistant will be responsible for sending introductory materials package to 
the participants. The introductory materials package include an Initial Contact Letter (see 
Form 1), Consent Form (see Form 2), Nerve Block Information (see Form 3), Intake 
Form and Quality of Recovery-15 Questionnaire (baseline) (see Form 4). The package 
will be emailed to the patients as well as sent out through mail. 
 
Patients who have received the Initial Contact Letter and have not declined to participate 
will be called by the research assistant 2-5 days after the email is sent out. Patients who 
do not have an email will be called 7-10 days after the mail is sent. All patient contact by 
the research assistant will be documented on Form 9: Recruitment Log. At this time, the 
research assistant will provide general information about the regional block study and 
confirm eligibility of the participant based on inclusion and exclusion criteria. If the 
patient is an eligible candidate, the research assistant will then provide a detailed 
description of the trial. 
 
If the patient is interested in participating in the study, the research assistant will discuss 
the study Consent Form with the patient and will provide an opportunity for the patient to 
ask any questions about the study before their surgery date. Verbal telephone consent will 
be documented in the Recruitment Log. If the patient expresses verbal consent to 
participate in the study, the research assistant will ask the patient to complete the Intake 

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Form and Quality of Recovery-15 Questionnaire (baseline) prior to the day of surgery. 
They will be asked to bring the forms along with the signed consent form on the day of 
the surgery. 
 
Research Assistants will call a day prior to the surgery to remind patients to complete the 
Intake Form and Quality of Recovery-15 Questionnaire (baseline) (Form 4) and bring 
these forms along with the Consent Form, on the day of surgery. Research assistants will 
answer any additional questions. 
 
On the day of surgery, the patient will meet with the research coordinator and sign the 
Consent Form to confirm their participation in the trial. Only once the Consent Form is 
signed will the collection of data begin.  
 
After signing the Consent Form, participants will receive a study ID number (i.e. NB01). 
The study ID number will be computer generated. The research assistant will match 
participant names to study ID numbers in a password-protected, encrypted Code Break 
linking list (Form 10) at the time of obtaining consent for participation in the study. 
Intake Form and Quality of Recovery-15 Questionnaire (baseline) (Form 4) will be 
collected by the research coordinator at this time. 
 
Patients who decline to participate in the study on the day of surgery will not receive a 
sham or local anesthetic regional block. These patients will receive the current standard 
of surgical care at MSJH. Current standard of care is an evidenced-based multimodal 
perioperative regime for optimizing recovery after surgery and General Anesthesia. 
Standard of care does not include routine use of regional blocks (see Appendix 2), 
however patients may request the regional block from the anesthesiologist. 
 
Participants will have their surgery scheduled within 2 months of enrolment. Involvement 
in the study will not affect the scheduling of surgery dates. Both participants and non-
participants will experience the same surgical timelines between their preoperative 
consults and their date of surgery. 
 
 
Outcome Measures  (back) 
 
Primary outcomes of the pilot trial: To demonstrate a reduction in chronic pain at 3 and 6 
months from 50% to 30% would require approximately 220 patients assuming  = 0.05 
(2-sided), =0.15.  Before embarking on a definitive multi-centre trial it is important to 
demonstrate feasibility and potential efficacy.64 
 
Feasibility: The definitive trial will be considered feasible if 1) > 50% of eligible patients 
are enrolled, 2) > 90% of blocks are successful, 3) retention at 6 months is > 90%. 
 
Preliminary evidence of efficacy: Although severe acute post-operative pain is not the 
only risk factor for chronic post-surgical pain (CPSP), an intervention that does not 
decrease postoperative pain is unlikely to have a significant impact on CPSP. If the 80% 

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confidence interval for the between-group difference in average pain score in the 24-hour 
postoperative period favours LA block, we will consider that preliminary evidence of 
efficacy.65,66 
 
Secondary outcomes of the pilot trial include adverse events related to study 
interventions. We will also collect the outcomes for the definitive trial to test and refine 
data collection processes.  
 
The primary outcome in the definitive trial is chronic pain, defined by the Pain Burden 
Index, measured at 3 and 6 months following surgery.  The Pain burden Index examines 
postsurgical pain in four postoperative body areas. The Index is calculated as a sum of the 
four locations (breast, chest, axilla, arm) multiplied by the frequency of pain12 (see Form 
8: Pain Burden Index).  
 
Secondary outcomes of the definitive trial include: 
 
• Opioid analgesia requirements during surgery and in the first 24 hours after 
surgery, defined as morphine milligram equivalents (MME). The total MME will 
include intraoperative opioids administered in the OR and postoperative opioids 
administered/ingested in the Postanesthetic Care Unit (PACU), Surgical Day Care 
Unit (SDC), Inpatient Unit, and home in the 24-hour period after completion of 
surgery. Opioids consumed will be converted to MME (see Appendix 3: 
Calculation of Morphine Milligram Equivalents (MME)).  
 
• Acute patient-reported pain scores: 
o Numerical Rating Scale (NRS; 11-point scale) measured at the standard 
time points of nursing care assessments: preoperatively (baseline); four 
times per hour in PACU until discharge; if admitted, hourly for 2 hours, 
and then every 6 hours in the Inpatient Unit; and at discharge from 
hospital; 24 hours after surgery is complete. 
 
• Opioid-induced side effects:  
o Postoperative nausea and vomiting 
 Nausea severity (by Verbal Rating Scale) in PACU 
 Vomiting episodes (0-48 hours after surgery) in PACU & home 
 
• Quality of recovery (Form 7: Quality of Recovery-15 Questionnaire) 
o Measured with the Quality of Recovery-15 (QoR-15) scores at baseline 
prior to surgery and 24 hours after surgery67-69. This 15-item questionnaire 
assesses patient-reported pain, physical comfort, physical independence, 
psychological support, and emotional state.69 It takes an average of 2.5 
minutes to complete. The QoR-15 has been statistically validated and is 
designed for both ambulatory and inpatient surgery populations.68,70  
 
• Length of stay (LOS) in hours in hospital 

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o Measured from the time admitted to PACU to the time discharged from 
hospital. LOS includes time in the PACU, Surgical Day Care (SDC) and, 
if required, Inpatient Unit. Patients are transferred between units and 
discharged from hospital according to standardized institutional criteria 
(see Appendix 4: PACU and SDC Discharge criteria).  
 
• Time-based outcome measures:  
o time to perform ultrasound-guided TPVB+  
o time under general anesthesia 
o time in PACU 
o failure of discharge from PACU and requiring admission 
 
• Rescue medications:  
o Need for rescue opioid analgesics and anti-emetics 
 Rescue medications are defined as those required “as needed” (ie. 
beyond scheduled) in the PACU, ward, and after discharge 
o Time to rescue opioid analgesics and anti-emetics 
 
• Failure of early discharge: 
o Emergency room visits within 48 hours of discharge  
 
• Complications and adverse events  
o Related to the ultrasound-guided regional block: vascular or nerve injury, 
Horner’s syndrome, bleeding/hematoma, local anesthetic systemic 
toxicity, pneumothorax, distortion tissue planes during axillary dissection, 
and other.  
o Related to the surgery: hematoma, tissue necrosis, urgent unplanned return 
to the operative theater within 24 hours of surgery.  
 
These measures are listed in Form 6: Clinical Form and Form 11: Data Collection Form.  
 
Sample Size 
 
240 IBR procedures are performed annually at MSJH, 50% participation yields ~ 30 
patients in 3 months. Assuming a difference of 1 and standard deviation of 1.2, this 
sample size yields > 80% probability that the lower bound will exclude 0.45 
 
 
Additional Details of Study Design 
 
Participants will also be given at the time of consent a post operative package.   
This will contain the Quality of Recovery-15 Questionnaire (Form 7), Recovery Booklet 
(Form 5) and Pain Burden Index (Form 8).  
 
The Quality of Recovery-15 Questionnaire (see Form 7) is to be completed at 24 
hours after surgery in paper format or electronic format (based on their preference). This 

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24 hour time point will be marked on the QoR-15 form. If paper format is preferred, the 
QoR-15 will be provided with a paid-postage envelope to return once completed at 24 
hours after surgery. The pain NRS at 24 hours will be recorded from the chart. The 
envelopes will be addressed to the research coordinator at UBC Hospital office. If the 
participant prefers electronic format, the questionnaire will be sent to their provided 
email address using secure online format (REDCap developed questionnaire). 
 
Recovery Booklet (see Form 5) will include: a) schedule for taking prescription 
pain medications; b) a postoperative 7-day symptom diary (for recording pain on NRS at 
24 hours, episodes of vomiting, nausea, and use of prescribed medications). Patients will 
be provided with a paid-postage envelope to return their Recovery Booklet via mail once 
completed at 7 days after surgery. Patients will be reminded to complete the Recovery 
Booklet (Form 5) in 3-4 days and once again at 14 days to return the envelope. 
 
The Pain Burden Index questionnaire (see Form 8) asks specifically about pain in 
four surgically related body areas and to calculate the Pain Burden Index (PBI). The PBI 
is calculated by summing the pain severity scale (0–10) at each of four locations (breast, 
axilla, chest wall, arm) multiplied by the frequency of the pain at each site. The PBI 
questionnaire will be sent to participants via mail as paper format (with paid-postage 
envelope to return once completed) or email as electronic format (as per their requested 
preference) to be completed 3 and 6 months after their surgery. Details of present 
adjuvant treatments (radiation and chemotherapy) will also be included in the 
questionnaire.  
 
Secondary outcomes data including opioid consumption and side effects, length 
of stay in hospital (hours), rescue medications, failure of early discharge, complications 
and adverse events and time-based outcome measures (time in PACU, time under general 
anesthesia, time to perform ultrasound-guided TPVB+, failure of discharge from PACU 
and requiring admission) will be collected through participants’ charts and EMR. 
  
 
Risk/Benefit Estimates  (back) 
 
Anticipated Benefits to Participants 
Participants will be randomly assigned to receive TPVB+ nerve blocks with either local 
anesthetic or sham (saline) followed by general anesthesia. 
 
Participants who are randomly assigned to saline infiltration for TPVB+ may not notice 
any improvement in postoperative pain scores, opioid requirements, side effects related to 
opioid consumption (eg. nausea and vomiting), chronic pain, or shortening of hospital 
stay. 
 
Participants who are randomly assigned to local anesthetic infiltration for TPVB+ may 
report reduced postoperative pain scores, require less total opioid analgesics or other 
medications in the perioperative period. Participants may experience fewer side effects 

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related to opioid consumption (eg. nausea and vomiting), may have lower risk of chronic 
pain, and may have shorter lengths of stay in hospital.  
 
All participants will be asked to reflect on their recovery and pain when completing the 
QoR-15 and PBI questionnaires. If appropriate, any issues flagged through completion of 
the QoR-15 or PBI questionnaire may be addressed to optimize participant recovery and 
optimize chronic pain control. 
 
Potential Harms or Risks to Participants 
Participants randomly assigned to the sham or local anesthetic TPVB+ followed by 
general anesthesia will be exposed to risks associated with the administration of regional 
blocks, such as (but not limited to) pain or discomfort at the time of the injection, 
hematoma, or pneumothorax. 
 
Adverse events from the TPVB have been reported in meta-analyses of randomized 
clinical trials. Failed anesthetic technique was the most common adverse event reported 
with a relative risk of 4.34 (CI 0.74 - 25.24).29 Other adverse events were rare with low 
relative risks: pneumothorax (RR 0.01, CI 0.02 – 0.03, occurs in 1 in 600 cases); post-
operative nausea and vomiting (RR 0.26, CI 0.13 – 0.5); nerve damage (n=0), and 
vascular injury (n=0).29 Horner’s syndrome (sympathetic blockade) has occurred in less 
than 1 in 100 cases.29 Nerve damage and vascular injury have a theoretical risk of 1 in 
over 1000 cases.29 Local infection has a theoretical risk of 1 in 2500 cases.71 Horner’s 
syndrome (temporary small pupil and droopy eyelid) has occurred in less than 1 of 100 
cases.29 
 
Participants receiving the saline TPVB+ may not experience improved pain scores or 
reduced opioid consumption postoperatively, unlike what is expected for participants 
receiving a local anesthetic regional block.  
 
Participants in this study, as compared to those not receiving regional anesthesia, may 
have an additional risk of Local Anesthetic Systemic Toxicity (LAST, a serious adverse 
reaction to local anesthetic occurring in less than 1 in 12,000 cases72), or other risks 
specific to the injection of local anesthetic. 
 
Risk/benefit discussions with prospective participants will occur at the time of consent 
for the study and participants will also have the opportunity during the PAC call/visit and 
on day of surgery to ask the anesthesiologist questions regarding the regional block 
procedure. Participants may contact the research assistant at any time before their surgery 
date with questions regarding the regional block procedure. Questions beyond the scope 
or knowledge of the research assistant will be forwarded to the appropriate study 
physician with expertise in anesthesiology or surgery. 
  
Assessment of Safety 
 
The safety of the TPVB+ have been established in the literature. There are rare 
complications associated with the blocks which will be clearly defined and outlined to the 

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participant during the recruitment phase of the study. The participant will have two 
separate occasions to ask the medical team and trained anesthesiologist for details on the 
regional anesthesia: during the PAC visit/phone call and preoperatively on the day of 
surgery. The TPVB+ will be performed by a consistent group of trained regional 
anesthesiologists.  
 
Adverse Events  
 
Adverse events related to study interventions (TPVB+) will be recorded and tracked as 
per the study Data Collection Form on REDCap.  
 
Statistical Analysis (back) 
 
Patient characteristics and outcome measures will be summarized by group.  An 80% 
confidence interval for the difference in average pain score over 24 hours will be 
calculated. 
 
Quality Control and Assurance 
 
All staff anticipated to be involved in the study, including anesthesiologists, general 
surgeons, plastic surgeons, research assistants, and nursing staff will be notified about the 
study and educated as appropriate on study interventions, data collection, and participant 
confidentiality. All staff providing study interventions (regional blocks), surgery, or 
perioperative care will be educated on relevant study outcomes being monitored.  
 
Protocols have been prepared for the study interventions to ensure a standardized 
approach (Appendix 1: Nerve Block Protocol; Appendix 2: Evidenced-Based Multimodal 
Perioperative Management Protocol for Alloplastic Immediate Breast Reconstruction; 
Appendix 4: PACU and SDC Discharge criteria; Appendix 5: Study Timeline). 
Standardized intake forms, clinical forms and participant questionnaires will be used to 
ensure that equivalent data is being collected for all participants (see Form 4: Intake 
Form, Form 5: Recovery Booklet, Form 6: Clinical Form, Form 7: Quality of Recovery-
15 Questionnaire, Form 8: Pain Burden Index).   
 
 
Detailed Research Protocols  (back) 
 
Please see Appendix 1: Nerve Block Protocol 
Please see Appendix 2: Evidenced-Based Multimodal Perioperative Management 
Protocol for Alloplastic Immediate Breast Reconstruction 
Please see Appendix 3: Calculation of Morphine Milligram Equivalents (MME) 
Please see Appendix 4: PACU and SDC Discharge criteria 
Please see Appendix 5: Study Timeline 
 
Forms  (back) 
 

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Please see Initial Contact Letter attached as Form 1.  
Please see Consent Form attached as Form 2. 
Please see Nerve Block Information attached as Form 3.  
Please see Intake Form and Quality of Recovery-15 Questionnaire (baseline) attached as 
Form 4.  
Please see Recovery Booklet attached as Form 5.  
Please see Clinical Form attached as Form 6. 
Please see Quality of Recovery-15 Questionnaire (24 hour follow-up) attached as Form 
7. 
Please see Pain Burden Index attached as Form 8. 
Please see Recruitment Log attached as Form 9. 
Please see Code Break linking list attached as Form 10. 
Please see Data Collection Form attached as Form 11.  
Please see Study Data Log attached as Form 12. 
 
 
Data Collection 
 
Data will be collected prospectively from the patients’ chart on the day of surgery, If 
required, the EMR will be accessed to obtain additional details. After collection of all 
data during the inpatient stay, data will be recorded under the anonymized study ID 
number by the research assistant. With the study ID number, data will be entered into 
REDCap. 
 
Participants will be randomly assigned to receive TPVB+ with local anesthetic or sham 
before general anesthesia. For all participants, data will be collected on the Intake Form, 
Clinical Form, Quality of Recovery-15 Questionnaire, Pain Burden Index, and Recovery 
Booklet in the following 7 sections: 
1. The Intake Form will be completed by the patient  during the initial contact 
phone call and includes information on general demographics and 
inclusion/exclusion criteria (without identifying information).  
2. The first section of the Clinical Form will be used to record information on the 
perioperative course including the type of surgery performed: unilateral or 
bilateral; partial or total mastectomy with or without sentinel lymph node 
biopsy or axillary lymph node dissection; tissue expander or immediate 
implant reconstruction; adjunctive procedures will be recorded including 
biopsies and balancing reduction procedures.  
3. The second section of the Clinical Form will record information on the general 
anesthesia provided; preoperative medications, intraoperative analgesics, 
sedatives, antiemetics, and anxiolytics. The form will also include details on 
the regional block and time to perform the block. Surgical and regional block 
complications within 24 hours of surgery will be recorded. 
4. The third section of the Clinical Form will include information on participant-
reported pain scores and medications in the postanesthetic care unit and 
inpatient ward.  

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5. The Quality of Recovery-15 Questionnaire will be completed by the participant 
at baseline before surgery and at 24 hours after surgery to evaluate the quality 
of their recovery. 
6. The Recovery Booklet will be completed by the participant during the first 7 
days after surgery to track scheduled and rescue medications required, opioid-
related side effects (nausea and vomiting), and pain at 24 hours after surgery. 
7. The Pain Burden Index will be completed by the participant 3 months and 6 
months after surgery to evaluate for the presence and severity of chronic pain.  
 
 
Confidentiality  (back) 
 
Management of Identifying Data: 
 
Identifying information collected from potential participants includes: name, phone 
number/email (optional, only if provided by participant), age/date of birth, PHN, and 
mailing address. This identifying information will be stored in the Code Break. All 
potential participants will be assigned a Recruitment ID number (i.e. R01). The 
identifying information from potential participants who opt not to participate in this study 
will be deleted from the Code Break. After consent is obtained, each participant will be 
assigned a study number (i.e. NB01). This study ID number will be recorded in the Code 
Break. Identifying information will only be stored in the Code Break, with the exception 
of email on REDCap as outlined below.  
 
The Code Break will be password-protected and stored on a secured UBC server. Email 
for the patients who opted for emailed surveys will be entered into REDCap.  
 
The Consent Form will be stored in a locked secured filing cabinet in the Principal 
Investigator’s (PI’s) Office.  
 
Management of Non-Identifying Data: 
 
All non-identifying information collected will be kept on the completed Recruitment Log, 
Study Data Log, Intake Form, Clinical Form, Quality of Recovery-15 Questionnaire, 
Recovery Booklet, and Pain Burden Index as hard copies in a locked secured filing 
cabinet in the Principal Investigator’s (PI’s) office.  
 
The Recruitment Log will record Recruitment ID number and consent progress. The 
Study Data Log containing tasks for research staff will be associated with Study ID 
number. The Recruitment Log and Study Data Log will not contain any identifying 
information.  
 
The hard-copy Intake Form and the Baseline Quality of Recovery-15 (QoR-15) 
Questionnaire (Form 4) will be collected at the time of enrollment. An additional Quality 
of Recovery-15 (QoR-15) Questionnaire (Form 7) will be provided on the day of surgery 
to be completed 24 hours postoperatively, before discharge from hospital and then mailed 

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back. Both the Intake Form and the Quality of Recovery-15 (QoR-15) Questionnaires 
will be stored with the other hard-copy study forms in a locked secured filing cabinet in 
the PI’s office. 
 
The hard-copy Recovery Booklet (Form 5) will be given to participants and completed 
over the course of 7 days postoperatively, before discharge from hospital. The Recovery 
Booklet will be stored with the other hard-copy study forms in a locked secured filing 
cabinet in the PI’s office. 
 
Data collected on the day of the surgery (Clinical Form: 6) will be directly inserted into 
REDCap web application. Should any unforeseen circumstance make direct data entry 
unavailable on the day of surgery, hard copies of Form 6 will be used as a backup. This 
will also be stored in a locked secured filing cabinet in the PI’s office 
 
The Pain Burden Index questionnaire (Form 8) will be given to participants and 
completed at 3 and 6 months after surgery. The patient will receive the questionnaire 1 
week before each of these dates and receive a phone call from the Research assistant to 
ensure receipt and answer any questions. The completed Pain Burden Index questionnaire 
will be stored with the other hard-copy study forms in a locked secured filing cabinet in 
the PI’s office. If the patient prefers emailed questionnaires, the questionnaire will be 
completed using a secure online survey format and anonymized to their assigned study 
ID number.  
 
The Data Collection Form outlines the variables and unit measures for the study and will 
not be used to store any data. Instead, participants’ data from the Intake Form, Clinical 
Form, Quality of Recovery-15 Questionnaire, Recovery Booklet, Clinical Form and Pain 
Burden Index will be collected and entered into the REDCap server directly through a 
password-protected encrypted laptop. No identifying information will be stored on 
REDCap except for email of the patients who have opted for electronic surveys.   
 
In summary, the Informed Consent, Intake Form, Clinical Form, Quality of Recovery-15 
Questionnaire, Recovery Booklet, and Pain Burden Index will be kept as hard copies in 
the PI’s office in a locked secured filing cabinet, separate from the Code Break linking 
list. Study Data Log and the Recruitment Log will be stored on the UBC server. All non-
identifying data collected will be stored on REDCap. Since the Code Break is stored 
separately from clinical data collected on REDCap, there is minimal risk of linking 
participants’ identifying information.  
 
 
 
 
 
 
 
 
 

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page 21 of 37 
 
 
Personal 
Identifying 
Information 
Storage 
 
Hard-Copy* 
REDCap 
Encrypted MS 
Excel Sheet† 
Informed Consent Form 
(Form 2) 
x 
x 
 
 
Intake Form (Form 4) 
 
x 
x 
 
Recovery Booklet (Form 5) 
 
x 
x 
 
Clinical Form (Form 6) 
 
x 
x 
 
Quality of Recovery-15 
Questionnaire (Form 7) 
 
x 
x 
 
Pain Burden Index (Form 8) 
 
x 
x 
 
Recruitment Log (Form 9) 
 
 
x 
Code Break (Form 10) 
x 
 
 
x 
Study Data Log (Form 12) 
 
 
 
x 
 
* Stored in Locked Cabinet in PI Office 
† Password protected and stored on secure UBC server 
 
 
Dissemination of Results 
Results will be disseminated through manuscript publication in a peer-reviewed 
journal and presented at a plastic surgery, surgical oncology, or anesthesiology 
conference. Results will also be disseminated through hospital in-services, educational 
rounds, or CME presentations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Project Timetable/Flowchart: (back) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participants recruited at 
plastic and reconstructive 
surgery clinic visit before 
surgery. 
Participants receive and 
complete Consent Form to 
enroll in study and 
complete intake form and 
baseline QoR-15
Participants randomly 
assigned to TPVB+ with 
local anesthetic.
Participants provide 
symptom scores during 
hospitalization and at home 
for 24 hours, complete QoR-
15 at 24 hours, Recovery 
Booklet for 7 days, and PBI at 
3 and 6 months.
Participants lost to follow-up 
or withdraw from study.
Participants randomly 
assigned to TPVB+ with 
saline.
Participants provide 
symptom scores during 
hospitalization and at home 
for 24 hours, complete QoR-
15 at 24 hours, Recovery 
Booklet for 7 days, and PBI at 
3 and 6 months.
Participants lost to follow-up 
or withdraw from study.
Participants lost to follow-
up or withdraw from study.

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References: (back) 
 
1. 
Canadian Cancer Advisory Committee. Canadian Cancer Statistics 2018. 2018. 
cancer.ca/Canadian-Cancer-Statistics-2018-EN.pdf. Accessed March 19, 2019. 
2. 
Platt J, Baxter N, Zhong T. Breast reconstruction after mastectomy for breast 
cancer. Canadian Medical Association journal (CMAJ). 2011;183(18):2109-2116. 
3. 
Zhong T, Fernandes KA, Saskin R, et al. Barriers to Immediate Breast 
Reconstruction in the Canadian Universal Health Care System. Journal of 
Clinical Oncology. 2014;32(20):2133-2141. 
4. 
Tasmuth T, Kataja M, Blomqvist C, Smitten Kv, Kalso E. Treatment-Related 
Factors Predisposing to Chronic Pain in Patients with Breast Cancer A 
Multivariate Approach. Acta Oncologica. 1997;36(6):625-630. 
5. 
Wallace AM, Wallace MS, Lee J, Dobke MK. Pain after breast surgery: a survey 
of 282 women. Pain. 1996;66(2-3):195-205. 
6. 
Gassman AA, Yoon AP, Festekjian J, Da Lio AL, Tseng CY, Crisera C. 
Comparison of immediate postoperative pain in implant-based breast 
reconstructions. Journal of Plastic, Reconstructive & Aesthetic Surgery. 
2016;69(5):604-616. 
7. 
Cordeiro PG. Breast Reconstruction after Surgery for Breast Cancer. The New 
England Journal of Medicine. 2008;359(15):1590-1601. 
8. 
Lennox PA, Bovill ES, Macadam SA. Evidence-Based Medicine: Alloplastic 
Breast Reconstruction. Plastic and Reconstructive Surgery. 2017;140(1):94e-
108e. 
9. 
Panchal H, Matros E. Current Trends in Post-Mastectomy Breast Reconstruction. 
Plastic and reconstructive surgery. 2017;140(5):7S-13S. 
10. 
Vadivelu N, Schreck M, Lopez J, Kodumudi G, Narayan D. Pain after 
mastectomy and breast reconstruction. Am Surg. 2008;74(4):285-296. 
11. 
Poleshuck EL, Katz J, Andrus CH, et al. Risk factors for chronic pain following 
breast cancer surgery: a prospective study. J Pain. 2006;7(9):626-634. 
12. 
Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of 
and factors associated with persistent pain following breast cancer surgery. JAMA. 
2009;302(18):1985-1992. 
13. 
Duenas M, Ojeda B, Salazar A, et al. Use and satisfaction with the Healthcare 
System of the chronic pain patients in Spain: results from a nationwide study. 
Curr Med Res Opin. 2016;32(11):1813-1820. 
14. 
Hamood R, Hamood R, Hamood H, et al. Chronic pain and other symptoms 
among breast cancer survivors: prevalence, predictors, and effects on quality of 
life. Breast Cancer Research and Treatment. 2018;167(1):157-169. 
15. 
Shah SB, Hariharan U, Bhargava AK. Recent trends in anaesthesia and analgesia 
for breast cancer surgery. Trends in Anaesthesia and Critical Care. 2018;20:11-
20. 
16. 
Alves Nogueira Fabro E, Bergmann, A., do Amaral e Silva, Blenda, Padula 
Ribeiro, A. C., de Souza Abrahão, K., da Costa Leite Ferreira, Maria Giseli, . . . 
Santos Thuler, L. C. . Post-mastectomy pain syndrome: Incidence and risks. 
Breast. 2012;21(3):321-325. 

Description: Nerve blocks in alloplastic breast reconstruction 
Version 2.1: November 13, 2020 
 
page 24 of 37 
17. 
Macdonald L, Bruce, J., Scott, N. W., Smith, W. C. S., & Chambers, W. A. Long-
term follow-up of breast cancer survivors with post-mastectomy pain syndrome. 
British Journal of Cancer. 2005(2):225-230. 
18. 
Spivey TL, Gutowski ED, Zinboonyahgoon N, et al. Chronic Pain After Breast 
Surgery: A Prospective, Observational Study. Ann Surg Oncol. 
2018;25(10):2917-2924. 
19. 
Schreiber KL, Martel MO, Shnol H, et al. Persistent pain in postmastectomy 
patients: Comparison of psychophysical, medical, surgical, and psychosocial 
characteristics between patients with and without pain. PAIN. 2013;154(5):660-
668. 
20. 
Dumestre DO, Webb CE, Temple-Oberle C. Improved Recovery Experience 
Achieved for Women Undergoing Implant-Based Breast Reconstruction Using an 
Enhanced Recovery after Surgery Model. Plastic and Reconstructive Surgery. 
2017;139(3):550-559. 
21. 
Persing S, Manahan M, Rosson G. Enhanced Recovery After Surgery Pathways in 
Breast Reconstruction. Clinics in Plastic Surgery. 2020;47(2):221-243. 
22. 
Temple-Oberle C, Shea-Budgell MA, Tan M, et al. Consensus Review of Optimal 
Perioperative Care in Breast Reconstruction: Enhanced Recovery after Surgery 
(ERAS) Society Recommendations. Plastic and reconstructive surgery. 
2017;139(5):1056e-1071e. 
23. 
Qin C, Antony AK, Aggarwal A, Jordan S, Gutowski KA, Kim JYS. Assessing 
Outcomes and Safety of Inpatient Versus Outpatient Tissue Expander Immediate 
Breast Reconstruction. Annals of Surgical Oncology. 2015;22(11):3724-3729. 
24. 
Simpson SABA, Ying BLBA, Ross LAMD, et al. Incidence of Complications in 
Outpatient Mastectomy with Immediate Reconstruction. Journal of the American 
College of Surgeons. 2007;205(3):463-467. 
25. 
Offodile Ii AC, Offodile Ii AC, Gu C, et al. Enhanced recovery after surgery 
(ERAS) pathways in breast reconstruction: systematic review and meta-analysis 
of the literature. Breast Cancer Research and Treatment. 2019;173(1):65-77. 
26. 
Parikh RP, Myckatyn TM. Paravertebral blocks and enhanced recovery after 
surgery protocols in breast reconstructive surgery: patient selection and 
perspectives. J Pain Res. 2018;11:1567-1581. 
27. 
Jacobs A, Lemoine A, Joshi GP, Van de Velde M, Bonnet F. PROSPECT 
guideline for oncological breast surgery: a systematic review and procedure-
specific postoperative pain management recommendations. Anaesthesia. 
2020;75(5):664-673. 
28. 
Sherwin A, Buggy DJ. Anaesthesia for breast surgery. BJA Education. 
2018;18(11):342-348. 
29. 
Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and 
safety of paravertebral blocks in breast surgery: a meta-analysis of randomized 
controlled trials. British Journal of Anaesthesia. 2010;105(6):842-852. 
30. 
Mazzinari G, Rovira L, Casasempere A, et al. Interfascial block at the serratus 
muscle plane versus conventional analgesia in breast surgery: a randomized 
controlled trial. Regional anesthesia and pain medicine. 2019;44(1):52. 
31. 
Parras T BR. PECS Blocks. World federation of societies of Anesthesiologists; 
2017. 

Description: Nerve blocks in alloplastic breast reconstruction 
Version 2.1: November 13, 2020 
 
page 25 of 37 
32. 
Blanco R. The ‘pecs block’: a novel technique for providing analgesia after breast 
surgery. Anaesthesia. 2011;66(9):847-848. 
33. 
Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II 
(modified Pecs I): a novel approach to breast surgery. Revista espanola de 
anestesiologia y reanimacion. 2012;59(9):470. 
34. 
Bashandy GMN, Abbas DN. Pectoral nerves I and II blocks in multimodal 
analgesia for breast cancer surgery: a randomized clinical trial. Regional 
anesthesia and pain medicine 2015;40(1):68. 
35. 
M N, Pandey RK, Sharma A, et al. Pectoral nerve blocks to improve analgesia 
after breast cancer surgery: A prospective, randomized and controlled trial. 
Journal of Clinical Anesthesia. 2018;45:12-17. 
36. 
Wang K, Zhang X, Zhang T, et al. The Efficacy of Ultrasound-guided Type II 
Pectoral Nerve Blocks in Perioperative Pain Management for Immediate 
Reconstruction After Modified Radical Mastectomy: A Prospective, Randomized 
Study. Clinical Journal of Pain. 2018;34:231-236. 
37. 
Goswami S, Kundra P, Bhattacharyya J. Pectoral nerve block1 versus modified 
pectoral nerve block2 for postoperative pain relief in patients undergoing 
modified radical mastectomy: a randomized clinical trial. British Journal of 
Anaesthesia. 2017;119(4):830-835. 
38. 
Abdallah FW, MacLean D, Madjdpour C, Cil T, Bhatia A, Brull R. Pectoralis and 
Serratus Fascial Plane Blocks Each Provide Early Analgesic Benefits Following 
Ambulatory Breast Cancer Surgery: A Retrospective Propensity-Matched Cohort 
Study. Anesthesia & Analgesia. 2017;125(1):294-302. 
39. 
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel 
ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013;68(11):1107-
1113. 
40. 
Abdallah FW, Cil T, MacLean D, et al. Too Deep or Not Too Deep?: A 
Propensity-Matched Comparison of the Analgesic Effects of a Superficial Versus 
Deep Serratus Fascial Plane Block for Ambulatory Breast Cancer Surgery. 
Regional anesthesia and pain medicine 2018;43(5):480. 
41. 
Bhoi D, Selvam V, Yadav P, Talawar P. Comparison of two different techniques 
of serratus anterior plane block: A clinical experience. Journal of Anaesthesiology 
Clinical Pharmacology. 2018;34(2):251-253. 
42. 
Gupta K, Srikanth K, Girdhar KK, Chan V. Analgesic efficacy of ultrasound-
guided paravertebral block versus serratus plane block for modified radical 
mastectomy: A randomised, controlled trial. Indian journal of anaesthesia. 
2017;61(5):381-386. 
43. 
Hards M, Harada A, Neville I, et al. The effect of serratus plane block performed 
under direct vision on postoperative pain in breast surgery. Journal of Clinical 
Anesthesia. 2016;34:427-431. 
44. 
Tahiri Y, Tran DQH, Bouteaud J, et al. General anaesthesia versus thoracic 
paravertebral block for breast surgery: A meta-analysis. Journal of Plastic, 
Reconstructive & Aesthetic Surgery. 2011;64(10):1261-1269. 
45. 
Terkawi AS, Tsang S, Sessler DI, et al. Improving Analgesic Efficacy and Safety 
of Thoracic Paravertebral Block for Breast Surgery: A Mixed-Effects Meta-
Analysis. Pain Physician. 2015;18(5):E757-780. 

Description: Nerve blocks in alloplastic breast reconstruction 
Version 2.1: November 13, 2020 
 
page 26 of 37 
46. 
Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-
Injection Paravertebral Block Before General Anesthesia Enhances Analgesia 
After Breast Cancer Surgery With and Without Associated Lymph Node Biopsy. 
Anesthesia & Analgesia. 2004;99(6):1837-1843. 
47. 
Coopey SB, Coopey SB, Specht MC, et al. Use of Preoperative Paravertebral 
Block Decreases Length of Stay in Patients Undergoing Mastectomy Plus 
Immediate Reconstruction. Annals of Surgical Oncology. 2013;20(4):1282-1286. 
48. 
Fahy AS, Jakub JW, Dy BM, et al. Paravertebral Blocks in Patients Undergoing 
Mastectomy with or without Immediate Reconstruction Provides Improved Pain 
Control and Decreased Postoperative Nausea and Vomiting. Annals of Surgical 
Oncology. 2014;21(10):3284-3289. 
49. 
Glissmeyer CBS, Johnson WMDMBA, Sherman BMD, Glissmeyer MPAC, 
Garreau JMD, Johnson NMD. Effect of paravertebral nerve blocks on narcotic 
use after mastectomy with reconstruction. American Journal of Surgery, The. 
2015;209(5):881-883. 
50. 
Kitowski NJ, Landercasper J, Gundrum JD, et al. Local and Paravertebral Block 
Anesthesia for Outpatient Elective Breast Cancer Surgery. Archives of Surgery. 
2010;145(6):592-594. 
51. 
Wolf O, Clemens MW, Purugganan RV, et al. A Prospective, Randomized, 
Controlled Trial of Paravertebral Block versus General Anesthesia Alone for 
Prosthetic Breast Reconstruction. Plastic and Reconstructive Surgery. 
2016;137(4):660e-666e. 
52. 
Pace MM, Sharma B, Anderson-Dam J, Fleischmann K, Warren L, Stefanovich P. 
Ultrasound-Guided Thoracic Paravertebral Blockade: A Retrospective Study of 
the Incidence of Complications. Anesthesia & Analgesia. 2016;122(4):1186-1191. 
53. 
Bouzinac A. BG, Dao M., Delbos A. Bilateral association of pecs I block and 
serratus plane block for postoperative analgesia after double modified radical 
mastectomy. Minerva Anestesiologica. 2015;81(5):589-590. 
54. 
Khemka R, Chakraborty A. Ultrasound-guided modified serratus anterior plane 
block for perioperative analgesia in breast oncoplastic surgery: A case series. 
Indian Journal of Anaesthesia. 2019;63(3):231-234. 
55. 
Khemka R, Chakraborty A, Ahmed R, Datta T, Agarwal S. Ultrasound-Guided 
Serratus Anterior Plane Block in Breast Reconstruction Surgery. A & A case 
reports. 2016;6(9):280-282. 
56. 
Sheehan L, Clark S, Britton G. A study looking at the effect of PEC/ Serratus 
nerve blocks on the incidence of persistent post-operative pain after breast cancer 
surgery. European Journal of Surgical Oncology. 2018;44(6):885-885. 
57. 
Matsumoto M, Flores EM, Kimachi PP, et al. Benefits in radical mastectomy 
protocol: a randomized trial evaluating the use of regional anesthesia. Scientific 
Reports. 2018;8(1):7815. 
58. 
Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block 
versus thoracic paravertebral block for postoperative analgesia after radical 
mastectomy: a randomized controlled trial. British Journal of Anaesthesia. 
2016;117(3):382-386. 

Description: Nerve blocks in alloplastic breast reconstruction 
Version 2.1: November 13, 2020 
 
page 27 of 37 
59. 
Wahba SS, Kamal SM. Thoracic paravertebral block versus pectoral nerve block 
for analgesia after breast surgery. Egyptian Journal of Anaesthesia. 
2014;30(2):129-135. 
60. 
Hussain N, Brull R, McCartney CJL, et al. Pectoralis-II Myofascial Block and 
Analgesia in Breast Cancer Surgery: A Systematic Review and Meta-analysis. 
Anesthesiology. 2019;131(3):630-648. 
61. 
Health BMo. Coronavirus COVID-19: A commitment to surgical renewal in B.C. 
. Government of British Columbia.  Published 2020. Updated May 7 2020. 
Accessed July 13, 2020. 
62. 
Evans MT, Wigmore T, Kelliher LJS. The impact of anaesthetic technique upon 
outcome in oncological surgery. BJA Education. 2018;19(1):14-20. 
63. 
Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic 
technique for primary breast cancer surgery affect recurrence or metastasis? 
Anesthesiology (Philadelphia). 2006;105(4):660-664. 
64. 
Avery K, Williamson P, Gamble C, et al. Informing efficient randomised 
controlled trials: exploration of challenges in developing progression criteria for 
internal pilot studies. BMJ Open. 2017;7. 
65. 
Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after 
surgery. Lancet. 2019;393(10180):1537-1546. 
66. 
Fletcher D, Stamer UM, Pogatzki-Zahn E, et al. Chronic postsurgical pain in 
Europe: An observational study. European Journal of Anaesthesiology | EJA. 
2015;32(10):725-734. 
67. 
Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and 
measurement of postoperative quality of recovery. Anaesthesia. 
2014;69(11):1266-1278. 
68. 
Kleif J, Waage J, Christensen KB, Gögenur I. Systematic review of the QoR-15 
score, a patient- reported outcome measure measuring quality of recovery after 
surgery and anaesthesia. British Journal of Anaesthesia. 2018;120(1):28-36. 
69. 
Stark PA, Myles PS, Burke JA. Development and Psychometric Evaluation of a 
Postoperative Quality of Recovery Score: The QoR-15. Anesthesiology. 
2013;118(6):1332-1340. 
70. 
Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and 
measurement of postoperatice quality of recovery. Anesthesia. 2014;69:1266-
1278. 
71. 
Alakkad H, Naeeni A, Chan VW, et al. Infection related to ultrasound-guided 
single-injection peripheral nerve blockade: a decade of experience at toronto 
Western hospital. Reg Anesth Pain Med. 2015;40(1):82-84. 
72. 
Sites BD, Taenzer AH, Herrick MD, et al. Incidence of local anesthetic systemic 
toxicity and postoperative neurologic symptoms associated with 12,668 
ultrasound-guided nerve blocks: an analysis from a prospective clinical registry. 
Reg Anesth Pain Med. 2012;37(5):478-482. 
73. 
Ho AL, Klassen AF, Cano S, Scott AM, Pusic AL. Optimizing patient-centered 
care in breast reconstruction: the importance of preoperative information and 
patient-physician communication. Plast Reconstr Surg. 2013;132(2):212e-220e. 

Description: Nerve blocks in alloplastic breast reconstruction 
Version 2.1: November 13, 2020 
 
page 28 of 37 
74. 
Snell L, McCarthy C, Klassen A, et al. Clarifying the expectations of patients 
undergoing implant breast reconstruction: a qualitative study. Plastic and 
reconstructive surgery. 2010;126(6):1825-1830. 
75. 
Sheehan J, Sherman KA, Lam T, Boyages J. Association of information 
satisfaction, psychological distress and monitoring coping style with post‐
decision regret following breast reconstruction. Psycho‐Oncology. 
2007;16(4):342-351. 
76. 
Zhong T, Hu J, Bagher S, et al. Decision Regret following Breast Reconstruction: 
The Role of Self-Efficacy and Satisfaction with Information in the Preoperative 
Period. Plastic and Reconstructive Surgery. 2013;132(5):724e-734e. 
77. 
Force AT. Practice Guidelines for Preoperative Fasting and the Use of 
Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application 
to Healthy Patients Undergoing Elective Procedures. Anesthesiology. 
2017;126(3):376-393. 
78. 
Brady M, Kinn S, Stuart P. Preoperative fasting for adults to prevent perioperative 
complications. 2003(4):CD004423. 
79. 
Feldheiser A, Aziz O, Baldini G, et al. Enhanced Recovery After Surgery (ERAS) 
for gastrointestinal surgery, part 2: consensus statement for anaesthesia practice. 
Acta Anaesthesiologica Scandinavica. 2016;60(3):289-334. 
80. 
Jiang Y, Li J, Lin H, et al. The efficacy of gabapentin in reducing pain intensity 
and morphine consumption after breast cancer surgery: A meta-analysis. 
Medicine. 2018;97(38):e11581. 
81. 
Rai ASMD, Khan JSMMD, Dhaliwal JB, et al. Preoperative pregabalin or 
gabapentin for postoperative acute and chronic pain among patients undergoing 
breast cancer surgery: A systematic review and meta-analysis of randomized 
controlled trials. Journal of Plastic, Reconstructive & Aesthetic Surgery. 2017. 
82. 
Clarke H, Bonin RP, Orser BA, Englesakis M, Wijeysundera DN, Katz J. The 
prevention of chronic postsurgical pain using gabapentin and pregabalin: a 
combined systematic review and meta-analysis. Anesthesia and analgesia. 
2012;115(2):428-442. 
83. 
Doleman B, Heinink TP, Read DJ, Faleiro RJ, Lund JN, Williams JP. A 
systematic review and meta‐regression analysis of prophylactic gabapentin for 
postoperative pain. Anaesthesia. 2015;70(10):1186-1204. 
84. 
Mathiesen O, Møiniche S, Dahl JB. Gabapentin and postoperative pain: a 
qualitative and quantitative systematic review, with focus on procedure. BMC 
anesthesiology. 2007;7(1):6-6. 
85. 
Apfelbaum JL, Silverstein JH, Chung FF, et al. Practice guidelines for 
postanesthetic care: an updated report by the American Society of 
Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 
2013;118(2):291-307. 
86. 
Erhan Y, Erhan Y, Erhan E, et al. Ondansetron, granisetron, and dexamethasone 
compared for the prevention of postoperative nausea and vomiting in patients 
undergoing laparoscopic cholecystectomy: A randomized placebo-controlled 
study. Surgical Endoscopy. 2008;22(6):1487-1492. 
87. 
Singh PM, Borle A, Panwar R, et al. Perioperative antiemetic efficacy of 
dexamethasone versus 5-HT3 receptor antagonists: a meta-analysis and trial 

Description: Nerve blocks in alloplastic breast reconstruction 
Version 2.1: November 13, 2020 
 
page 29 of 37 
sequential analysis of randomized controlled trials. European Journal of Clinical 
Pharmacology. 2018;74(10):1201-1214. 
88. 
De Oliveira JGS, Castro-Alves LJS, Ahmad S, Kendall MC, McCarthy RJ. 
Dexamethasone to prevent postoperative nausea and vomiting: an updated meta-
analysis of randomized controlled trials. Anesthesia and analgesia. 
2013;116(1):58-74. 
89. 
Feo CV, Sortini D, Ragazzi R, De Palma M, Liboni A. Randomized clinical trial 
of the effect of preoperative dexamethasone on nausea and vomiting after 
laparoscopic cholecystectomy. British Journal of Surgery. 2006;93(3):295-299. 
90. 
Cortés-Flores AO, Jiménez-Tornero J, Morgan-Villela G, et al. Effects of 
preoperative dexamethasone on postoperative pain, nausea, vomiting and 
respiratory function in women undergoing conservative breast surgery for cancer: 
Results of a controlled clinical trial. Eur J Cancer Care (Engl). 2018;27(1). 
91. 
Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative 
dexamethasone on postoperative analgesia and side-effects: systematic review and 
meta-analysis. BJA: British Journal of Anaesthesia. 2012;110(2):191-200. 
92. 
Gómez-Hernández J, Orozco-Alatorre AL, Domínguez-Contreras M, et al. 
Preoperative dexamethasone reduces postoperative pain, nausea and vomiting 
following mastectomy for breast cancer. BMC Cancer. 2010;10(1):692. 
93. 
Gallagher M, Jones DJ, Bell-Syer SV. Prophylactic antibiotics to prevent surgical 
site infection after breast cancer surgery. 2019;9:CD005360. 
94. 
Uppal V, Sondekoppam RV, Sodhi P, Johnston D, Ganapathy S. Single-Injection 
Versus Multiple-Injection Technique of Ultrasound-Guided Paravertebral Blocks: 
A Randomized Controlled Study Comparing Dermatomal Spread. Regional 
anesthesia and pain medicine 2017;42(5):575. 
95. 
Elhakim M, Nafie M, Mahmoud K, Atef A. Dexamethasone 8 mg in combination 
with ondansetron 4 mg appears to be the optimal dose for the prevention of 
nausea and vomiting after laparoscopic cholecystectomy. Canadian Journal of 
Anesthesia. 2002;49(9):922-926. 
96. 
Toms L, McQuay HJ, Derry S, Moore RA. Single dose oral paracetamol 
(acetaminophen) for postoperative pain in adults. 2008(4):CD004602. 
97. 
Busse JW, Guyatt GH, Carrasco A, et al. The 2017 Canadian Guideline for 
Opioids for Chronic Non-Cancer Pain - National Pain Centre. 
http://nationalpaincentre.mcmaster.ca 2017. 
98. 
Physicians AAoF. Opioid Conversion Table. 
https://www.aafp.org/dam/AAFP/documents/patient_care/pain_management/conv
ersion-table.pdf. Published 2018. Accessed Dece,ber 3rd, 2019. 
99. 
Services LMP. Appendices - Vancouver Acute: Equianalgesic Opioid Dosing. 
Vancouver Acute Adult Parenteral Drug Therapy Manual Web site. 
http://pdtm.vch.ca/monograph-information/appendices/vancouver-acute. . 
Published 2018. Accessed December 20, 2019. 
 
 
 
 
 

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Appendix 1: Nerve Block Protocol: TPVB+ (TPVB with Pec I block)  (back) 
 
All sham and LA blocks will be performed by a regional anesthesiologist experienced in 
performing TPVB and Pec I blocks. The blocks will be performed in the preoperative 
block room. Participants will be monitored as per existing site policy. The blocks will be 
done using sterile technique. Before and after each procedure, the ultrasound machine 
will be cleaned and disinfected using disinfectant wipes and allowed to air dry as per 
hospital/site policy. 
 
1. Prior to the procedure, the patient will have the procedure explained to them, and 
consent documented as per hospital policy. Standard monitors and a safety check 
will be performed.  Sedation medication (midazolam 1-2mg and fentanyl 25-
50mcg) will be given.  
2. The regional anesthesiologist will prepare syringes for injection of sham and 
regional anesthetic blocks depending on patient allocation.  
3. Syringes for injection may include: 
a. LA TPVB block: 25ml of 0.3% ropivacaine with 1:400K epinephrine 
b. LA Pecs I  block:10ml of 0.3% ropivacaine with 1:400K epinephrine  
c. Sham TPVB block: 25ml normal saline (0.9% NaCl) 
d. Sham Pecs I block: 10ml normal saline (0.9% NaCl) 
4. The skin at the planned injection site will be cleansed with 2% chlorhexidine 
solution or 1% iodine (10% povidone iodine) in case of chlorhexidine allergy.  
5. Nonsterile conducting gel will be applied to the 9 MHz linear probe ultrasound 
transducer, and the transducer will be covered with a sterile drape. 
6. The anesthesiologist will don a clean face mask and sterile gloves prior to 
handling sterile equipment or touching the sterile field.  
7. Sterile ultrasound conducting gel will be applied to the skin. 
8. Local anesthetic skin wheal will be raised with 1% lidocaine. 
9. TPVB block: The T2/3 or 3/4 interspace will be determined by counting ribs with 
the ultrasound.  The ultrasound probe will be place in a sagittal orientation aiming 
to visualize the transverse processes. The location of the pleura will be noted and 
the LA will be injected in the paravertebral space incrementally after negative 
aspiration looking for pleural drift.  For the sham injection the needle will be 
inserted to just superficial to the transverse process for an erector spinae plane 
injection (between erector spinae muscles and the transverse processes). 
10. Pecs I block: Infiltrate will be injected into the fascia between the pectoralis 
minor and pectoralis major muscles at the level of the 3rd rib in the mid-to-lateral 
1/3 of the clavicle in a transverse to oblique orientation. Identification of the 
pectoral branch of the thoracoacromial artery will assist with needle placement. 
The needle will be inserted from medial/superior to lateral/inferior. Visual 
confirmation will be by ultrasound upon visualizing the separation of tissue layers 
with the injected infiltrate.   
11. The needle and probe will be removed and the injection site wiped dry. 
12. The patient will continuous monitored in the block area until ready for transport 
to the operating for surgery. 

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Appendix 2: Evidenced-Based Multimodal Perioperative Analgesia and Anti-emetic 
Management Protocol for Alloplastic Immediate Breast Reconstruction (back) 
 
PREOPERATIVE 
1- Patient Education: 
a. Information on options, risks/benefits, recovery 73-76 
2- Fasting & Nutrition: 
a. Allow clear fluids up to 2 hours before arrival to the hospital and no solid 
foods after midnight 26,77-79  
3- Preoperative Analgesics: 21 to be given in preop 30 minutes to 2 hours pre-
induction 
a. Gabapentin 600mg po x1 27,80-84 
b. Acetaminophen 1000mg po x 1   
c. Celecoxib 400mg po x 121 
d. Midazolam 1-4mg IV PRN during nerve block administration only 
e. Fentanyl 25-100mcg IV PRN during nerve block administration only 
4- Preoperative anti-emetics: to be given in block room 
a. Dexamethasone 8mg IV 85-92  
i. by Anesthesiologist in block room by slow infusion 
5- Preoperative Antibiotics: to be given in block room 
a. Preoperative antibiotics within 60 minutes of incision 93 
i. by Anesthesiologist in block room 
6- Regional Anesthesia: Paravertebral block with Pecs I (TPVB+)57,94 (Intervention) 
a. Paravertebral T3/4 block: 0.3% ropivacaine+1:400K epi x 25mL  
b. Pecs I block with 0.3% ropivacaine with 1:400 epi x 10mL 
c. TOTAL nerve block LA volume 0.3% ropivacaine x 35 mL = 105mg for 
50kg patient 
 
 
 
 
 
INTRAOPERATIVE 
1- General Anesthesia 
a. Induction with Propofol (2-4mg/kg IV), Fentanyl (1-4mcg/kg IV), 
Rocuronium (0.5-1.2mg/kg IV) 
b. Endotracheal intubation 
c. Maintenance with inhalational Sevoflurane (0.6-1.2 MAC) 
d. Opioid as needed for hemodynamic stability (eg. Fentanyl 0.25-1mcg/kg 
IV boluses, Hydromorphone to maximum 2mg IV or Morphine to 
maximum 15mg IV) 
e. Ondansetron 4mg IV 30 mins before emergence from general anesthesia 
85,86,88,95 
f. Reversal of muscle relaxant at discretion of OR anesthesiologist with 
Neostigmine or Sugammadex IV 
2- Sequential Compression Devices & Warming blanket 
3- Breast block: 18cc of [0.25% bupivacaine with 1:400 000 epinephrine] diluted in 
18cc of NS to give total volume of 36cc of [0.125% bupivacaine with 1:400 000 
epinephrine] per patient prior to incision 

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POSTOPERATIVE  (POSTANESTHETIC CARE UNIT) 
1- Celecoxib 200mg po x1 21  
2- Acetaminophen 1000mg PO q6h 96 
3- Ondansetron 4mg po/IV q6h  
4- Gravol 25-50mg po/IV q4-6h PRN 
5- Hydromorphone 0.2-0.4mg IV q5min PRN 
6- Fentanyl 25mcg – 50mcg IV q15min PRN 
7- Oxycodone 5mg-10mg po q4h PRN  
 
POSTOPERATIVE  (INPATIENT UNIT) 
1- Celecoxib 200mg po bid for 2 doses 21  
2- Acetaminophen 1000mg PO q6h 96 
3- Ondansetron 4mg po/IV q6h for 72 hours 
4- Gravol 25-50mg po/IV q4-6h PRN 
5- Hydromorphone 0.2-0.4mg IV q5min PRN 
6- Oxycodone 5mg-10mg po q4h PRN 
7- Gabapentin 200mg po qhs 20,21 
8- Keflex 500mg po qid for 7 days 
 
PRESCRIPTION (At discharge, as per instructions in Recovery Booklet) 
1- Tramacet 1 – 2 tablets po q6h  (40 tablets) 21 
i. After Tramacet finished, Acetaminophen 500mg po qid  
2- Celecoxib 200mg po bid for 2 doses 20 
i. After celecoxib finished: Ibuprofen 400mg po tid 20,21 
ii. Note: if discharge delayed, order for celecoxib adjusted for a maximum of 2 
doses after discharge from PACU 
3- Gabapentin 200mg po qhs for 2 doses 20,21 
i. Note: if discharge delayed, order for gabapentin adjusted for a maximum of 2 
doses after discharge from PACU 
4- Ondansetron 4mg po qid for 72 hours  
i. Note: if discharge delayed, order for ondansetron adjusted for a maximum 
duration of 72 hours after discharge from PACU 
5- Keflex 500mg po qid for 7 days 
i. Note: if discharge delayed, order adjusted to complete a 7-day course 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 3: Calculation of Morphine Milligram Equivalents (MME) (back) 
 
 
Opioid 
To convert to oral morphine milligram 
equivalent (MME), multiply dose of 
drug (in mg) by:* 
Codeine 
0.15 
Hydromorphone 
5 
Morphine 
1 
Oxycodone 
1.5 
Tramadol 
0.15 
*Conversion ratios for opioids can vary based on individual patient drug metabolism, 
which may be influenced by genetics and other medications. 
 
 
Fentanyl 0.01 (10mcg) IV = Equivalent to Morphine 5mg 
  
Table is adapted from National Guidelines for Opioid Conversion97,98 and local Health 
Authority Opioid Conversion Table for Fentanyl.99 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix 4: PACU and SDC Discharge criteria (back) 
 
 
PACU Discharge Criteria (1 of 2) 
 
 
 
 
Table is adapted from Providence Health Care Nursing Standards, B-00-1310071- PACU 
Post Anesthesia Protocol, Published by Providence Health Care, January 2017. 
 
 
 
 
 

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Appendix 4: PACU and SDC Discharge criteria (continued) 
 
 
PACU Discharge Criteria (2 of 2) 
 
 
 
 
Table is adapted from Providence Health Care Nursing Standards, B-00-1310071- PACU 
Post Anesthesia Protocol, Published by Providence Health Care, January 2017. 
 
 
 

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Appendix 4: PACU and SDC Discharge criteria (continued) 
 
SDC Discharge Score 
 
 
 
Table is adapted from Providence Health Care Nursing Standards, Form  PHC-PA 002, 
Surgical Day Care Postoperative record, Published by Providence Health Care, 
September 2017. 
 
 
 
 
 

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Appendix 5: Study Timeline (back) 
  
Flow Diagram outlining the data collection timepoints.