Clinical trial NCT03700970
Conditions: Breast Reconstruction Anesthesia Transverse Abdominis Plane Block
Sponsor: Vanderbilt University Medical Center
Start date: 2019-06-13; Completion date: 2021-03-30
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.

Detailed description:
Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).

Arms: arm 1: Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. arm 2: Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side.
Interventions: intervention 1: Liposomal bupivacaine intervention 2: Regular bupivacaine
Intervention descriptions: intervention 1: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. intervention 2: 20mL of 0.25% bupivacaine injected on each side.

Protocol documents:
ICF_000.pdf: 
 
 
 
[Year] 
NCT ID # 03700970 
   
Title: Comparing Local Anesthetics for Transversus 
Abdominis Plane (TAP) Block During Abdominally-
based Free Flap for Breast Reconstruction 
 
             10/01/2018 
 
      
 


Institutional Review Board 
Informed Consent Document for Research 
Date of IRB Approval: 07/18/2019 
Date of Expiration: 07/17/20210of 
 
 
 
 
Principal Investigator: XXXXXX MD 
Revision Date: October 1, 2018 
Study Title: Comparing local anesthetics for transversus abdominis plane block during abdominally-based free flap for breast reconstruction 
Institution/Hospital: Vanderbilt University Medical Center 
 
This informed consent applies to Adults 
 
Name of participant: 
Age:   
 
 
The following is given to you to tell you about this research study. Please read this form with care and ask any questions you 
may have about this study. Your questions will be answered. Also, you will be given a copy of this consent form. 
 
You do not have to be in this research study. You may choose not to be in this study and get other treatments without changing your 
healthcare, services or other rights. You can stop being in this study at any time. If we learn something new that may affect the risks or 
benefits of this study, you will be told so that you can decide whether or not you still want to be in this study. Your medical record will 
contain a note saying you are in a research study. Anyone you authorize to receive your medical record will also get this note. 
 
1. What is the purpose of this study? 
You are being asked to take part in this research study because you are having surgery to rebuild your breast(s). 
As part of your pain control plan, you will receive an injection of a drug into the muscles and tissues of the 
abdomen. This will reduce pain and swelling. This is called a TAP (transversus abdominis plane) block. The 
purpose of this study is to compare two different drugs used to control pain to see if one is better than the other. 
The drugs used in this study are: liposomal bupivacaine and plain bupivacaine. 
 
These drugs are approved by the Food and Drug Administration (FDA). About 60 people will take part in this 
study at VUMC. 
 
2. What will happen and how long will you be in the study? 
If you want to take part in this study you will sign this consent form. Your medical records will be reviewed to 
make sure you are able to take part in this study. You will complete questionnaires which will take about 15 
minutes. You will be randomized (like the flip of a coin) to receive liposomal bupivacaine with plain bupivacaine or 
plain bupivacaine alone. You will not know which drug you are getting. 
 
On the day of your surgery: A TAP block will be done after you receive general anesthesia in the operating room. 
This means you will not be aware when this procedure is done. The anesthesiologist will use ultrasound to help 
guide a needle into a space in your abdominal muscles on each side. After the needle is inserted, liposomal 
bupivacaine with plain bupivacaine or plain bupivacaine alone will be injected in the space. After the medication 
is injected, the needle will be removed. 
 
You will be given pain medicine as needed during and after surgery as part of your regular care. You will be 
asked questions about your pain every day while you are in the hospital and on post-op Day 7. 
 
Follow-up: The study team will contact you about 4 times during your recovery period to ask questions about how 
you are recovering: Day 0-7; Day 7, Day 14 and Day 30. Each time point will take about 10 minutes. These will be 
completed in clinic or by phone call. 
 
Your participation in this study will last about 30 days. 
 
3. Costs to you if you take part in this study: 
 
If you agree to take part in this research study, you and/or your insurance will not have to pay for the tests and 
treatments that are being done only for research. 
 
However, you are still responsible for paying for the usual care you would normally receive for the treatment of 
your illness. This includes treatments and tests you would need even if you were not in this study. These costs 
will be billed to you and/or your insurance. 


Institutional Review Board 
Informed Consent Document for Research 
Date of IRB Approval: 07/18/2019 
Date of Expiration: 07/17/20220of 
 
 
Principal Investigator:  Galen Perdikis, MD 
Revision Date: October 1, 2018 
Study Title: Comparing local anesthetics for transversus abdominis plane block during abdominally-based free flap for breast reconstruction 
Institution/Hospital: Vanderbilt University Medical Center 
 
You have the right to ask what it may cost you to take part in this study. If you would like assistance, financial 
counseling is available through the Vanderbilt Financial Assistance Program. The study staff can help you 
contact this program. You have the right to contact your insurance company to discuss the costs of your routine 
care (non-research) further before choosing to be in the study. You may choose not to be in this study if your 
insurance does not pay for your routine care (non-research) costs and your doctor will discuss other treatment 
plans with you. 
 
4. Side effects and risks that you can expect if you take part in this study: 
 
Liposomal bupivacaine and/or plain bupivacaine 
Common 
• 
nausea, vomiting; 
• 
chills or shivering; 
• 
headache; or 
• 
back pain. 
 
Uncommon 
• 
feeling anxious, restless, confused, or like you might pass out; 
• 
problems with speech or vision; 
• 
ringing in the ears, metallic taste, numbness or tingling around your mouth, or tremors; 
• 
seizure (convulsions); 
• 
weak or shallow breathing; 
• 
fast heart rate, gasping, feeling unusually hot; 
• 
slow heart rate, weak pulse; 
• 
urinating less than usual or not at all. 
 
Rare 
• 
allergic reaction 
 
Risks of a TAP block may include: 
• 
infection at the insertion site (where the needle enters your body) 
• 
temporary numbness 
• 
reaction to the anesthesia 
• 
anesthesia injected into a blood vessel instead of the muscle 
 
5. Payment in case you are injured because of this research study: 
 
If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the tests or 
treatments that are done for research, then you and/or your insurance will not have to pay for the cost of 
immediate medical care provided at Vanderbilt to treat the injury. 
 
There are no plans for Vanderbilt to pay for any injury caused by the usual care you would normally receive for 
treating your illness or the costs of any additional care. There are no plans for Vanderbilt to give you money for 
the injury. 
 
6. Good effects that might result from this study: 
a) The benefits to science and humankind that might result from this study. Data gathered in this study will provide 
information about pain control and recovery using these two study drugs. 
 
b) The benefits you might get from being in this study. You may or may not benefit from taking part in this study. 
 
7. Other treatments you could get if you decide not to be in this study: 


Institutional Review Board 
Informed Consent Document for Research 
Date of IRB Approval: 07/18/2019 
Date of Expiration: 07/17/20230of 
 
 
Principal Investigator:  Galen Perdikis, MD 
Revision Date: October 1, 2018 
Study Title: Comparing local anesthetics for transversus abdominis plane block during abdominally-based free flap for breast reconstruction 
Institution/Hospital: Vanderbilt University Medical Center 
 
You do not have to take part in this study. 
 
8. Payments for your time spent taking part in this study or expenses: 
You will not be paid to take part in this study. 
 
9. Reasons why the study doctor may take you out of this study: 
 
• 
The study doctor may take you out of this study if they feel that it is not good for you to continue. 
• 
You withdraw consent. 
• 
The study stops. 
 
If you are taken out of the study you will be told the reason. 
 
10. What will happen if you decide to stop being in this study? 
If you decide to stop being part of the study, you should tell your study doctor. Deciding to not be part of the study will 
not change your regular medical care in any way. 
11. Who to call for any questions or in case you are injured: 
If you should have any questions about this research study, Please contact study PI 
For additional information about giving consent or your rights as a person in this study, to discuss problems, concerns, 
and questions, or to offer input, please call the Vanderbilt University Institutional Review Board Office at 
(615) 322-2918 or toll free at (866) 224-8273. 
 
12. Clinical Trials Registry. 
A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. This Web site will 
not include information that can identify you. At most, the Web site will include a summary of the results. You can 
search this Web site at any time. 
13. Confidentiality: 
Your study records will be stored within Vanderbilt University Medical Center: either in locked areas with limited access 
or within electronic data bases with access limited to the study team only. 
Vanderbilt may share your information, without identifiers, to others or use it for other research projects not listed in this 
form. Vanderbilt, Dr. Perdikis and his staff will comply with any and all laws regarding the privacy of such information. 
There are no plans to pay you for the use or transfer of this de-identified information. 
14. Authorization to Use/Disclose Protected Health Information 
 
 
All efforts, within reason, will be made to keep your protected health information (PHI) private. PHI is your health 
information that is, or has been gathered or kept by Vanderbilt as a result of your healthcare. This includes data gathered 
for research studies that can be traced back to you. Using or sharing (“disclosure”) such data must follow federal privacy 
rules. By signing the consent for this study, you are agreeing (“authorization”) to the uses and likely sharing of your PHI. If 
you decide to be in this research study, you are also agreeing to let the study team use and share your PHI as described 
below. 
 
As part of the study, Vanderbilt University Medical Center may share the results of your study and/or non-study linked 
parts of your medical record, to the groups named below. These groups may include people from the Federal Government 
Office for Human Research Protections, the VUMC Institutional Review Board, Vanderbilt University, the Food and Drug 


Institutional Review Board 
Informed Consent Document for Research 
Date of IRB Approval: 07/18/2019 
Date of Expiration: 07/17/20240of 4 
 
 
Principal Investigator:  Galen Perdikis, MD 
Revision Date: October 1, 2018 
Study Title: Comparing local anesthetics for transversus abdominis plane block during abdominally-based free flap for breast reconstruction 
Institution/Hospital: Vanderbilt University Medical Center 
 
Administration (FDA), the Vanderbilt Anesthesiology Research Executive Committee (AREC) and insurance companies 
for billing purposes. Federal privacy rules may not apply to these groups; they have their own rules and codes to assure 
that all efforts, within reason, will be made to keep your PHI private. The study results will be kept in your research record 
for at least six years after the study is finished. At that time, the research data that has not been put in your medical 
record will be kept for an unknown length of time. Any research data that has been put into your medical record will be 
kept for an unknown length of time. 
 
The study results will be kept in your research record for at least six years after the study is finished. At that time, the 
research data that has not been put in your medical record will be kept for an unknown length of time. Any research data 
that has been put into your medical record will be kept for an unknown length of time. 
 
Unless told otherwise, your consent to use or share your PHI does not expire. If you change your mind, we ask that you 
contact Dr. Perdikis in writing and let him know that you withdraw your consent. His mailing address is D4207 MCN, 
Nashville, TN 37232-2345. At that time, we will stop getting any more data about you. But, the health data we stored 
before you withdrew your consent may still be used for reporting and research quality. 
 
If you decide not to take part in this research study, it will not affect your treatment, payment or enrollment in any 
health plans or affect your ability to get benefits. You will get a copy of this form after it is signed. 
 
STATEMENT BY PERSON AGREEING TO BE IN THIS STUDY 
I have read this consent form and the research study has been explained to me verbally. All my 
questions have been answered, and I freely and voluntarily choose to take part in this study. 
 
 
 
Date 
Signature of patient/volunteer 
 
Consent obtained by: 
 
 
Date 
Signature 
 
 
Printed Name and Title 

SAP_002.pdf: 
Study Title: Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and 
Plain Bupivacaine in Transversus Abdominis Plane For Deep Inferior Epigastric Artery 
Perforator (DIEP) Flap Breast Reconstruction 
NCT # 03700970 
Document date: October 1, 2018 
 
Statistical Analysis 
Patient characteristics were summarized as appropriate, using mean (standard deviation [SD]) 
and median (25th-75th interquartile range [IQR]) for quantitative variables and counts 
(percentages) for qualitative variables. Unadjusted comparisons of patients between the plain 
bupivacaine group and the liposomal bupivacaine group were performed using Wilcoxon test or 
Pearson chi-square test. The effect of the study intervention on daily oral opioid intake in oral 
morphine equivalents (OME) was examined using linear mixed effects regression model, 
adjusting for post-operative day (as a categorical variable), intervention status (plain 
bupivacaine/ liposomal bupivacaine), and their interaction. Since there were repeated 
measurements of OME for 7 post-operative days, a random intercept indexed by subject number 
was used in the linear mixed effects regression model. All analyses were performed using the R 
Programming Language 3.3.0 (R Foundation for Statistical Computing, Vienna, Austria). P<0.05 
was considered a statistically significant difference. 
 
Sample size calculations were based on demonstrating superiority of the TAP block with 
liposomal bupivacaine. A simulation-based power analysis was used to evaluate statistical power 
under the following assumptions: 1) use of linear mixed effects regression after log 
transformation of the opioid intake outcome, 2) average opioid consumption on days 0, 1, 2, and 


3 is 30, 90, 70 mg mEq under standard of care, 3) use of liposomal bupivacaine will result in a 
20% reduction in opioid consumption at each study day, and 4) the between- and within-subjects 
coefficients of variation are 20% and 60%, respectively (these values are based on standard of 
care data from our institution). Thus, the minimum-detectable difference is a 20% reduction in 
average opioid consumption at each study day. Under these assumptions, 60 participants are 
needed to achieve 80% power. 
 

Prot_001.pdf: 
 
1
Protocol Title:  
Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and 
Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap 
for Breast Reconstruction 
 
Protocol Version Date: 
10/01/2018 
 
 
NCT #   03700970 
 
Principal Investigator: 
Galen Perdikis, MD – Professor, Department of Plastic Surgery, Vanderbilt University 
Medical Center 
D-4207 Medical Center North, Nashville, TN 37232-2345 
 
Sub-Investigators: 
Uma Devi Shastri, MD – Assistant Professor, Department of Anesthesiology, Vanderbilt 
University Medical Center 
Matthew David McEvoy, MD – Professor, Department of Anesthesiology, Vanderbilt 
University Medical Center 
Kye Higdon, MD – Associate Professor, Department of Plastic Surgery, Vanderbilt 
University Medical Center 
Lyly Nguyen, MD – Department of Plastic Surgery, Vanderbilt University Medical Center 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
2
 
 
Background 
Perioperative and postoperative analgesia is a high priority for patients undergoing plastic 
and reconstructive surgery. It is of particular interest in patients undergoing abdominally-
based free flaps for breast reconstruction (e.g., deep inferior epigastric artery perforator 
flaps) that includes excision of abdominal skin and subcutaneous tissue since the majority 
of pain after these operations is derived from the abdominal donor site  (Jablonka et al, 
PRS 2017). Although intravenous and oral opioids have been the mainstay of postoperative 
pain control for this patient population, they are associated with a number of detrimental 
effects that can delay recovery and increase length of hospital stay. For example, they can 
lead to nausea, vomiting, constipation, lethargy, cough suppression, confusion, and 
orthostatic hypotension (Pizzi et al; Pharmacotherapy 2012). By reducing these side 
effects, resumption of a normal diet and ambulation can be achieved faster, which can 
accelerate recovery. This is turn can lead to decreased length of hospital stay and its 
associated cost, as well as improvement in the perceived quality of life for this patient 
population.  
 
Local analgesia, in the form of transversus abdominis plane (TAP) block that is 
administered in the operating room prior to the incision under ultrasound guidance, has 
been advocated to provide improved analgesia in the perioperative and postoperative 
periods. This is a promising approach that can decrease or even eliminate the need for 
narcotics in the postoperative period.  This is a standard procedure at VUMC, and part of 
the Enhanced Recovery Pathway, for patients undergoing abdominally-based free flap 
breast reconstruction.  However, there is debate regarding the best local anesthetic for these 
purposes. Liposomal bupivacaine has been used widely and is believed to provide adequate 
analgesia for more than 48 hours after surgery. On the other hand, plain bupivacaine is 
significantly cheaper and has also been shown to have promising and lasting analgesic 
results.  To date, there are not randomized trials comparing the two local analgesics in a 
well-defined group of plastic surgery patients in general and also specifically in patients 
undergoing abdominally-based free flap breast reconstruction. 
 
 
Rationale and Specific Aims 
This study is designed to compare the efficiency of TAP blocks using liposomal 
bupivacaine versus plain bupivacaine that is administered in the operating room under 
ultrasound guidance prior to the incision in patients undergoing abdominally-based free 
flap breast reconstruction.  
 
The primary aim of the study will be to compare the amount of supplemental postoperative 
narcotic analgesia (both intravenous and oral) required by the study groups in oral 
morphine equivalents from postoperative days 0 to 7. The amount of postoperative 
analgesia will be documented daily until postoperative day 7. It will be obtained from the 
medical records during hospitalization, and with daily phone calls after the patients get 
discharged with instructions to document this data daily. 
 


 
3
The secondary aims will be: 
1) Pain control, as measured by a visual analog NPS number ranging from 0 (no pain 
at all) to 10 (worst pain ever) between the 2 groups. This will be evaluated 
immediately after surgery in the postanesthesia care unit (PACU), on the day of 
surgery and all subsequent postoperative days until discharge and on postoperative 
day 7. In the PACU patients will be asked about their current pain. For the inpatient 
postoperative days and postoperative day 7, patients will be asked to record their 
average, current, and maximum Numeric Pain Scale (NPS) score for the previous 
24 hours 
2) Time to first opiate use: time from end of surgery (i.e. patient went to recovery or 
ICU) until time of first opioid intake)  
3) Time to return of bowel function: time from end of surgery (i.e. patient went to 
recovery or ICU)  
4) Incidence of narcotic complications (i.e. nausea, vomiting, constipation, urinary 
retention, dizziness, etc.); defined as the number of occurrences of the complication 
per day for the first 7 days after surgery 
5) Quality of life (QoL) as measured with: 
Baseline (during consenting before surgery): WHODAS, QoR-15, PROMIS-29 
0-7 days: QoR-15 
Day 7 and 14: PROMIS-29 
Day 30:  PROMIS-29, WHODAS 
 
 
Inclusion/Exclusion Criteria 
Inclusion criteria will include:  
1) age between 18-85 years 
2) males or females 
3) plastic surgery for abdominally-based free flap breast reconstruction.  
 
Exclusion criteria will include:  
1) those not candidates for TAP blocks due to allergies to the medications (e.g., 
bupivacaine)  
2) those with anatomic contra-indications to performing a TAP block  
3) those unwilling to participate in follow-up assessments 
4) vulnerable populations 
5) chronic pain or associated diagnosis 
 
 
Enrollment/Randomization 
Patients undergoing abdominally-based free flap breast reconstruction under general 
anesthesia will be randomized to receive a TAP block with either liposomal bupivacaine 
or plain bupivacaine to determine if narcotic requirements and/or pain control is better 
achieved with one of the above methods. Patients in this study will be recruited in the 
plastic surgery outpatient clinics. No advertising will be done and there will be no 
recruitment tactics.  
 


 
4
Patients eligible for the study will be seen by the participating attendings at Vanderbilt 
University Medical Center, or one of their associates. The patient will be told about the 
study and given an opportunity to read the consent. If they wish to participate, they will be 
asked to sign the consent.  
 
Participants will be randomized to receive liposomal bupivacaine or plain bupivacaine in 
a permuted block fashion, in block of sizes 2 or 4. For each block, block size will be 
selected uniformly at ransom. This method of randomization ensures balance between 
groups following every second or fourth allocation. The patients will be randomized after 
providing written informed consent in the outpatient clinic. Following randomization, the 
plastic surgeons performing the surgery and assessments will be blinded to study treatment 
arm. Patients will also be blinded to the study treatment arm. The anesthesia team and some 
of the ancillary research staff will not be blinded to study treatment arm. 
 
 
Study Procedures 
Patients randomly assigned to the liposomal bupivacaine group or plain bupivacaine group 
will receive this intervention intra-operatively prior to the initiation of surgery. 
 
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the 
operating room after the patient is intubated and under general anesthesia. Transfascial 
injections will be performed by the anesthesiologist using an epidural needle. Under sterile 
conditions and ultrasound guidance, the fascial plane between the internal oblique and 
transversus abdominis muscles (muscles of the abdominal wall) will be identified at the 
anterior axillary line, midway between the costal margin and iliac crest. The epidural 
needle will be inserted through the skin to the appropriate fascial plane, and the local 
anesthetic will be injected in that plane. Then the needle will be removed and discarded, 
and the patient will be prepped and draped to start the surgery. 
 
Liposomal bupivacaine group:  20mL of Exparel® 1.3% mixed with 20mL of 0.25% 
bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each 
side. 
 
Regular bupivacaine group:  20mL of 0.25% bupivacaine injected on each side. 
 
The Anesthesia team will follow standard care procedures regarding perioperative pain 
management (including preoperative, intraoperative, and postoperative analgesic 
regimens). Patients in all groups will also receive instructions in the preoperative period 
dictating the recommended approach to postoperative pain control. 
 
 
Risks 
Injection with the local anesthetic may cause participants to experience some discomfort, 
redness or a small bruise at the site of the injections. These will be temporary and will 
disappear in a couple of days. 
 


 
5
With any nerve block there is a very small possibility of damage to the nerve, which could 
result in numbness of the surrounding area. According to the medical literature the 
likelihood of this injury is 1 in 10000 to 1 in 100000.   
 
In rare cases the local anaesthetic may be absorbed into the bloodstream. In such rare 
scenario, the systemic absorption of the local anaesthetic may cause one of the following 
side effects: 
▪ Slow-irregular heartbeats, low blood pressure, abnormal heartbeats, and cardiac 
arrest (2.3 events every 100,000 patients). 
▪ Toxicity to the brain, including seizures (13.7 events every 100,000 patients); 
▪ Respiratory arrest (4.6 events every 100,000 patients). 
 
The blocks are performed in a monitored setting in the operating room.  Patients are 
connected to monitors including blood pressure cuff, ECG and oxygen saturation.  These 
monitors allow close monitoring for any signs of local anesthetic toxicity.  The area is 
equipped with all resuscitation medication and equipment, and personnel are adequately 
trained in treatment of these complications.  
 
Blocks are performed under direct ultrasound guidance so full visualization of the needle 
and the local anesthetic is observed.  This will protect against nerve injury.  
 
 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others; Study Withdrawal/Discontinuation 
The progress of the study will be discussed formerly at regularly scheduled research 
meetings. These will serve as a forum for the voicing of concerns or problems with the 
study. If participant safety is a concern, the research investigators will immediately notify 
the P.I.  Adverse events will be reported to the IRB according to IRB policies and 
procedures, as there are specific guidelines at IRB Policy and Procedure III.L.1 that must 
be followed.  
 
Local anesthetic toxicity or nerve injury will be considered serious adverse events.  Also 
allergic reactions to the local anesthetic will be considered adverse events. These patients 
will be withdrawn from the study and appropriate treatment will be instituted.  The 
anesthesia care team will identify such an event and report it.  
 
 
Statistical Considerations 
Sample size calculations were based on demonstrating superiority of the TAP block with 
liposomal bupivacaine. 
 
The sample size calculation for the oral morphine equivalent requirements was based on 
one of our previous studies on Enhanced Recovery Pathway for free flap breast 
reconstruction. Calculations showed that randomizing 60 patients will obtain 80% power 
to detect a difference between the two groups. 
 


 
6
 
Privacy/Confidentiality Issues 
Collected data will be stored in a password protected REDCapTM database with sole access 
delineated by the investigators and study personnel of the study.  
 
 
Follow up and Record Retention 
The data will be extracted from the EMR via of EPIC (eStar) and entered in a RedCapTM 
database. Paper copies of the surveys will be kept in a locked cabinet by the investigators 
of the study until study completion of all data analysis and then subsequently securely 
destroyed. 
 
Collected data will include demographics, amount of supplemental postoperative narcotic 
analgesia both intravenous and oral, visual analog pain scale, time to return of bowel 
function, time to first opiate use, incidence of narcotic complications, and Quality of Life. 
Some of these variables will be collected at several times points as described above. 
 
Records will be retained for 6 years following the study completion.  
 
 
References 
Jablonka EM, Lamelas AM, Kim JN, et al. Transversus Abdominis Plane Blocks with 
Single-Dose Liposomal Bupivacaine in Conjunction with a Nonnarcotic Pain Regimen 
Help Reduce Length of Stay following Abdominally Based Microsurgical Breast 
Reconstruction. Plast Reconstr Surg. 2017 Aug; 140(2):240-251. 
 
Hivelin M, Wyniecki A, Plaud B, et al. Ultrasound-guided bilateral transversus abdominis 
plane block for postoperative analgesia after breast reconstruction by DIEP flap. Plast 
Reconstr Surg. 2011 Jul; 128(1):44-55 
 
Practice guidelines for acute pain management in the perioperative setting. A report by the 
American Society of Anesthesiologists Task Force on Pain Management, Acute Pain 
Section. Anesthesiology. 1995; 82(4):1071-81. 
 
Yu N, Long X, Lujan-Hernandez JR, et al.Transversus abdominis-plane block versus local 
anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-
analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15; 14:121.  
 
Knackstedt R, Gatherwright J, Ghaznavi A, et al. Comparison of local anesthetic infusion 
pump bupivacaine versus transversus abdominis plane (TAP) block liposomal bupivacaine 
for pain management after bilateral deep inferior epigastric perforator free flap 
reconstruction. J Plast Reconstr Aesthet Surg. 2017 Dec; 70(12):1779-1781. 
 
Ayad S, Babazade R, Elsharkawy H, et al. Comparison of Transversus Abdominis Plane 
Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus 
Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15; 11(4):e0153675.