Clinical trial NCT04254692
Conditions: Postoperative Pain
Keywords: abdominoplasty enhanced recovery after surgery Liposomal bupivacaine
Sponsor: University of Wisconsin, Madison
Start date: 2021-01-05; Completion date: 2021-01-21
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of postoperative nausea and vomiting (PONV), and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in 46 participants 18 years and older undergoing elective abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.

Detailed description:
Postoperative pain, nausea, and vomiting can be frustrating sequelae of elective surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. Despite the use of multiple techniques for managing postoperative pain in abdominoplasty patients, pain control continues to be a challenge for this patient population.

One technique commonly employed to improve pain control is the use of abdominal wall and incisional injection of local anesthetic agents to block the sensory nerves supplying the anterior abdominal wall and abdominal incisions in order to decrease sensation and pain in the abdomen in the setting of abdominoplasty surgery. Local anesthetic often used in this procedure is bupivacaine (Marcaine) ± epinephrine. However, in 2012, a liposomal bupivacaine suspension (Exparel; Pacira BioSciences, Inc, San Diego, California) was introduced as a longer-acting local anesthetic used for management of postoperative pain. At the University of Wisconsin, patients undergoing abdominoplasty routinely receive intraoperative injection of local anesthetic to the abdominal wall and abdominal incisions, using bupivacaine as the local anesthetic, along with standard multimodal perioperative pain management including cool compresses, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids.

The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in optimizing pain control, minimizing the risk of PONV, and improving recovery after abdominoplasty. This will be done by comparing intraoperative abdominal wall and incisional injection of bupivacaine to bupivacaine plus liposomal bupivacaine in patients undergoing abdominoplasty. This will be studied using pain assessments, validated surveys, medication logs and review of medical records.

Arms: arm 1: Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. arm 2: Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.
Interventions: intervention 1: Liposomal bupivacaine intervention 2: Standard of care
Intervention descriptions: intervention 1: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall. intervention 2: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall

Protocol documents:
Prot_SAP_000.pdf: 
PROTOCOL  
 
 
 
 
 
 
 
         NCT04254692 
 
Title: Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty 
 
Protocol:  
- 
Version 2 – 04/09/2021 
 
 
PI:  
Venkat Rao, MD, MBA1 
Professor of Surgery, Division of Plastic Surgery 
 
 
Affiliation:  
 
Department of Surgery-Division of Plastic Surgery 
University of Wisconsin School of Medicine and Public Health 
G5/350 Clinical Sciences Center 
600 Highland Ave 
Madison, WI 53792 
 
 


Project Summary 
 
Postoperative pain, nausea, and vomiting can be frustrating sequelae of elective surgery. Poorly 
managed postoperative pain can lead to increased opioid use, increased postoperative nausea and 
vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical 
complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, 
any intervention that potentially minimizes opioid use may have meaningful individual and societal 
impact. Despite the use of multiple techniques for managing postoperative pain in abdominoplasty 
patients, pain control continues to be a challenge for this patient population.  
 
One technique commonly employed to improve pain control is the use of abdominal wall and 
incisional injection of local anesthetic agents to block the sensory nerves supplying the anterior 
abdominal wall and abdominal incisions in order to decrease sensation and pain in the abdomen in the 
setting of abdominoplasty surgery. Local anesthetic often used in this procedure is bupivacaine 
(Marcaine) ± epinephrine. However, in 2012, a liposomal bupivacaine suspension (Exparel; Pacira 
BioSciences, Inc, San Diego, California) was introduced as a longer-acting local anesthetic used for 
management of postoperative pain1. At the University of Wisconsin, patients undergoing abdominoplasty 
routinely receive intraoperative injection of local anesthetic to the abdominal wall and abdominal 
incisions, using bupivacaine as the local anesthetic, along with standard multimodal perioperative pain 
management including cool compresses, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, 
and opioids.  
 
The overall purpose of this study is to evaluate the analgesic efficacy of liposomal bupivacaine in 
optimizing pain control, minimizing the risk of PONV, and improving recovery after abdominoplasty. We 
will do this by comparing intraoperative abdominal wall and incisional injection of bupivacaine to 
bupivacaine plus liposomal bupivacaine in patients undergoing abdominoplasty. This will be studied 
using pain assessments, validated surveys, medication logs and review of medical records.  
 
Background and Significance 
 
Abdominoplasty is a routine plastic surgery procedure commonly performed on an outpatient 
basis, with more than 150,000 procedures performed in the US in 20182. In this operation the abdominal 
muscles are tightened with sutures to improve the abdominal contour. This tightening of the muscles can 
increase muscle spasm and pain. Postoperative pain management in these patients can be challenging, 
resulting in decreased patient satisfaction, delayed recovery including delayed return to work and daily 
activities, increased opioid pain medication requirements and occasionally unplanned hospital admissions, 
surgical complications, and increased cost of care1.  
 
Abdominal wall and incisional injection of local anesthetics are commonly used as an adjunctive 
pain control technique for abdominoplasty and other surgeries involving the abdominal wall. Although 
local anesthetics are effective in treatment of postoperative pain, their relatively short duration of action 
(typically less than 8 hours) can make postoperative pain management challenging. This short duration of 
action is due to systemic absorption and subsequent elimination of the anesthetic limiting its time of 
contact with the local nerve endings3. Since its introduction in 2012, liposomal bupivacaine has been 
widely used as a local anesthetic in controlling postoperative pain. Liposomal bupivacaine is a dose-
dependent slow-release formulation that consists of bupivacaine in an aqueous core enclosed inside a 
liposome. The liposomal preparation prevents the rapid systemic abruption of bupivacaine and allows it to 
remain at the injection site for a longer period as well as its gradual release overtime4. Liposomal 
bupivacaine demonstrates an initial peak analgesic effect immediately after injection, due to the presence 
of extra-liposomal bupivacaine in the solution, followed by a delayed peak occurring within 10-36 hours 
after administration. This is in contrast to non-liposomal bupivacaine that has a duration of up to 8 hours3.  


 
To date, there have been several studies looking at the use of bupivacaine as the local anesthetic 
in these techniques in abdominoplasty patients. However, no prospective, randomized, blinded study has 
been performed to evaluate the analgesic efficacy of liposomal bupivacaine in the same setting. Sforza et 
al.5 performed a double-blinded, randomized controlled trial to assess the analgesic efficacy of TAP block 
using 0.25% bupivacaine versus standard of care in 28 women undergoing elective abdominoplasty. In 
this study, the TAP block cohort demonstrated significantly lower pain scores, lower morphine 
requirements in the first 12 postoperative hours, and also exhibited early ambulation compared to the 
control group. In a retrospective chart review of 64 female patients undergoing abdominoplasty with 
abdominal field block injections, using liposomal bupivacaine as local anesthetic, Morales et al.1 reported 
reduced postoperative pain, lower postoperative opioid requirements, and earlier resumption of normal 
activity and ambulation compared to studies using other anesthetics for nerve blocks.  
 
Thus, the overarching goal of this study is to prospectively evaluate the safety and efficacy of 
intraoperative abdominal wall and incisional injection of bupivacaine plus liposomal bupivacaine, 
compared to standard bupivacaine alone in abdominoplasty patients. We are conducting this study 
because, to our knowledge, no previous study has prospectively evaluated postoperative pain optimization 
in abdominoplasty patients using abdominal wall and incisional injection of bupivacaine plus liposomal 
bupivacaine as local anesthetic. We hypothesize that the use of bupivacaine plus liposomal bupivacaine 
will improve postoperative pain, minimize the risk of PONV and improve patient experience in 
abdominoplasty surgery beyond standard of care.  
 
Experimental Design 
 
This study will assess safety and efficacy of intraoperative abdominal wall and incisional 
injection of liposomal bupivacaine suspension in abdominoplasty patients. We hope that results from this 
study will help guide clinical decision-making with respect to postoperative pain management and overall 
optimization of recovery in elective plastic surgery.  
 
The primary aim in this study is to evaluate postoperative total opioid use, measured via 
morphine equivalent (ME) dose, on postoperative day 1 (POD 1) in patients receiving either bupivacaine 
and epinephrine or bupivacaine plus liposomal bupivacaine and epinephrine injections intraoperatively 
during abdominoplasty. Additional outcomes include quality of recovery scores on POD1, pain scores on 
POD1, pain score at 1 week post op, total opioids (ME) at 1 week post op, use of antiemetic medication, 
development of PONV, time to discharge, patients’ assessment of quality of recovery as determined by a 
validated survey and overall patient satisfaction. 
 
Research Design and Methods 
 
Target population 
i. 
Male or female patients undergoing abdominoplasty by Dr. Venkat Rao, Dr. Ahmed Afifi or 
Dr. John Siebert, at Madison Surgery Center (MSC).  
 
Inclusion criteria 
i. 
Age equal to and greater than 18 years. 
ii. 
Medically cleared to undergo elective surgery (including associated anesthesia) at Madison 
Surgery Center. 
 
Exclusion criteria 
i. 
Minors or under the age of 18 
ii. 
Pregnant or breast-feeding women 


iii. 
Incarcerated women or men 
iv. 
Individuals unable to give consent due to another condition such as impaired decision-making 
capacity. 
v. 
Men or women who take opioid pain medications on a regular basis prior to surgery. 
vi. 
Men or women with a history of opioid abuse and/or dependence. 
vii. 
Patients with a history of bleeding disorders precluding safe abdominoplasty 
viii. 
Patients with renal and hepatic impairment 
ix. 
Patients on anticoagulation therapy who have not held their anticoagulation as recommended 
by their surgeon or anesthesiologist. 
x. 
Patients not medically cleared for surgery at Madison Surgery Center. This would include 
patients with sepsis/bacteremia, significant valvular disorders or heart conditions. 
 
Recruitment and Group Selection: 
 
Patients seeking abdominoplasty who are seen by one of the participating attending physicians 
and meet all inclusion and exclusion criteria will be approached to participate in this study. Participation 
in this study is voluntary. Patients interested in participation in this study who meet all inclusion and 
exclusion criteria will be approached to participate in this study. Those patients interested in participation 
in this study will be consented for participation per IRB approved process. The consent process will only 
be completed by study personnel who have completed the necessary training to do so.  
 
All patients, regardless of study group / treatment arm, will undergo routine preoperative workup 
and management that all patients undergoing abdominoplasty with the attending physicians routinely 
undergo. 
 
Study Outcome Measures 
 
To prospectively determine the safety and efficacy of intraoperative abdominal wall and 
incisional injection of liposomal bupivacaine on perioperative pain and postoperative recovery following 
abdominoplasty, we will use total opioid use (ME) on POD 1 to evaluate our primary endpoint. To 
determine the safety and efficacy of intraoperative injection of liposomal bupivacaine on secondary 
endpoints of this study (quality of recovery POD1, pain score POD1, pain score 1 week post op, total 
opioid 1 week post op [ME], total antiemetic medication use POD 1, total antiemetic medication use 1 
week post op), we will use Quality of Recovery assessments (QOR-40)6–8, as well as perform chart 
review and collect patient surveys that gather this information. To gather descriptive data, (including 
demographic information, average time [minutes] spent in the PACU, average time [minutes] spent in 
Phase 2, total time [minutes] between the end of the operation and discharge to home, and evaluate the 
occurrence of unplanned hospital admission, PONV) we will perform review of medical records, surveys, 
and postoperative diaries. 
 
The primary outcome is total opioid use (ME) on POD 1. Secondary outcomes include QOR-40 
score on POD 1, pain score on POD1, pain score 1 week post op, total opioids (ME) 1 week post op, total 
antiemetic medication use POD 1, total antiemetic medication use 1 week post op. 
 
Group Descriptions 
 
Patients electing to undergo abdominoplasty will be invited to participate in the study at their 
preoperative visit. All patients choosing to take part in the study will be consented prior to their 
procedure. The study participants will consist of Dr. Venkat Rao, Dr. Ahmed Afifi and Dr. John Siebert’s 
patients. The study participants will be randomized to one of two groups using block randomization. 
Block randomization will be performed using a computer-generated number list and an Excel spreadsheet 


template; this will ensure equal numbers of subjects in each group. The subject will be randomized to 
receive either (a) intraoperative abdominal wall and incisional bupivacaine and epinephrine injection or 
(b) intraoperative abdominal wall and incisional bupivacaine plus liposomal bupivacaine and epinephrine 
injection. Intraoperative abdominal wall and incisional injection will be performed by the attending 
surgeon or appropriately trained surgical resident, using small aliquots, targeting sensory nerves in the 
abdominal wall and the abdominal incision. Surgery will take place in the usual fashion and participants 
will receive standard of care for pain control. Standard postoperative pain control includes: 
acetaminophen (Tylenol) 650-1000mg every 6 hours (obtained over the counter); Ibuprofen 600-800mg 
every 8 hours (obtained over the counter); Oxycodone 5-10mg every 4-6 hours as needed- 25 tablets total 
prescribed. 
 
Following surgery, patients will be assessed for quality of recovery, postoperative pain, nausea 
and vomiting. Assessment of quality of pain will consist of a validated VAS score. VAS will also be 
administered prior to transfer to phase II postoperatively and at their one-week postoperative visit. 
Assessment of postoperative quality of recovery will consist of a validated QOR-40 score on POD 1. 
Participants will also be asked to record, using a postoperative diary/log, when they take postoperative 
analgesics and antiemetics, which medications are taken, and quantity of medication taken. This will also 
be reviewed both in the medical record and upon discussion with the participant at the postoperative 
visits. Assessment of the time spent in the recovery room, time spent in Phase 2 of recovery, will be 
obtained via review of the medical record. At the first postoperative visit, participants will undergo a 
routine interview that includes discussion of their pain control, analgesic and antiemetic use, recovery 
process, and overall satisfaction. The medical record will be reviewed for any unplanned postoperative 
hospital readmissions related to the surgery and for any referral placed for pain medication management 
after completion of peri-operative care.  
 
Study Procedures 
 
Abdominoplasty will be performed in the standard fashion, and all patients will receive routine 
management as deemed appropriate by the surgeon and anesthesiologist regardless of treatment arm. 
Postoperatively, all patients will proceed to the recovery room/PACU, where they will receive routine 
postoperative cares, including standard ASA monitoring, and availability of analgesics and antiemetics. 
Prior to transfer from PACU to Phase II, all patients will be asked to assess their pain, including rate their 
pain on a 0 to 10 numeric rating scale (where 10 is associated with the “worst pain ever” and 0 is 
associated with no pain).  
 
Each participant will be transferred from PACU to Phase 2 when he or she meets standard 
requirements for transfer. Patient will be discharged when all discharge criteria have been met. All other 
postoperative patient care will be routine for all patients undergoing abdominoplasty. 
 
Per our routine care for patients undergoing abdominoplasty, post-operative medications for all 
patients, regardless of study group, will include 5-10mg oxycodone every 4-6 hours as needed, 600-
800mg ibuprofen every 8 hours and 650-1000mg acetaminophen every 6 hours. Patients are typically 
prescribed 25 tablets of oxycodone, and are encourage to take acetaminophen and ibuprofen scheduled as 
above for the first 5 days post-operatively, and then on an as-needed basis.  
 
Data collection will occur intra-operatively, in PACU, on POD1 and POD 7. Medical record 
review will be performed to collect intra-operative and PACU data. Patients will be asked to fill out 3 
surveys on POD 1- VAS, QOR-40 and POD 1 survey. They will also be asked to complete a medication 
log and pain diary until POD 7. These surveys will be collected at their 1 week post-operative visits.  
 
 


Intraoperative local anesthetic injection 
 
Regional analgesia techniques are routinely performed at Madison Surgery Center; all members 
of the perioperative team (nursing staff, anesthesiologists, and surgery team) understand the risks of local 
anesthetics and the facility is equipped and prepared to address potential complications. 
 
The injection of local anesthesia to the abdominal wall will be performed intraoperatively. The 
patient will be positioned supine on the surgical table during the procedure. The patient, the 
anesthesiologist and the postoperative nursing staff will not be informed regarding whether bupivacaine 
and epinephrine or bupivacaine plus liposomal bupivacaine and epinephrine is being used as the local 
anesthetic. The surgical attending and resident assisting will be the only team members informed 
regarding which local anesthetic is being injected. All intraoperative local anesthetic injections will be 
performed by the attending surgeon or resident appropriately trained in the injection technique. Patients 
will undergo initial abdominoplasty procedure in the standard fashion. Prior to closure of abdomen, either 
bupivacaine and epinephrine or bupivacaine plus liposomal bupivacaine and epinephrine will be injected 
into the abdominal wall, targeting the plane between the transversus abdominus and internal oblique 
muscles, and the incision line. 
 
A 25 gauge 50 or 80 mm needle will be used for the injection of local anesthetic. A 20-30 mL 
syringe of either 0.25% bupivacaine with 2.5 mcg/mL of epinephrine or 0.25% bupivacaine mixed with 
liposomal bupivacaine with 2.5 mcg/mL of epinephrine, depending on the study group, will be connected 
to the needle and used for injection. Local anesthetic will be injected bilaterally. Patients weighing at least 
40kg will either receive approximately 80mL of 0.25% bupivacaine with 2.5mcg/mL epinephrine or 
80mL of bupivacaine plus liposomal bupivacaine (20mL containing 266mg of liposomal bupivacaine 
mixed with 60mL of 0.25% bupivacaine containing 150mg of bupivacaine) with 2.5 mcg/mL of 
epinephrine. This will be divided into 2 separate injections of approximately 40mL, divided equally in 
multiple small aliquots on each side. The injections will also performed along the surgical abdominal 
incision. 
 
A list of liposomal bupivacaine side effects can be found under the Data and Safety Monitoring 
section of the protocol. Any adverse event related to local anesthetic will be handled in the same manner 
that is standard clinical practice at Madison Surgery Center. Local anesthetics are used frequently at 
Madison Surgery Center. Local anesthetic toxicity may occur if the dose of bupivacaine or liposomal 
bupivacaine is miscalculated. In the event of any emergency, patient will be treated in the same clinical 
practice standards that are applied to all patients undergoing surgery at Madison Surgery Center. 
 
Statistical Methods 
 
 Our primary outcome of interest is total opioid use (ME) on POD 1 between the two study groups; 
Patient receiving local anesthetic injection using bupivacaine as local anesthetic and patient receiving 
local anesthetic injection using bupivacaine plus liposomal bupivacaine as local anesthetic. Outcome 
metrics are the same between the 2 groups. 
We reviewed previously published studies prior to performing a power calculation to identify a 
sample size. Data on the use of total opioid use (ME) in abdominoplasty was limited, however, we found 
data published by Fiala et al.9 in 2015 most similar to our study design. In that study, the treatment group 
received intraoperative TAP block and their total hydromorphone use was compared to the control group. 
Based on 16 subjects per group, they found averages of 4.31mg and 2.63mg in control and treatment 
groups respectively and a resulting p-value of 0.024. This means the pooled standard deviation of the 
groups must have been around 2. Using a two-tailed, two sample t-test, performed at a significance level 


of 0.05, we would need 23 subjects per group in order to have at least 80% power for finding a similar 
effect as significant. Power calculation was performed with the assistance of a biostatistician. 
 
Our primary outcome of interest is total opioid use (ME) on POD 1. Additional outcomes of interest 
include QOR-40 score, pain score POD1, pain score 1 week post op, total opioid (ME) 1 week post op, 
total antiemetic medication use POD 1, total antiemetic medication use 1 week post op. 
There will be 46 patients enrolled in the study (23 in each group, with 2 total groups) and therefore the 
medical record for 46 patients will be accessed to determine basic demographic information, analgesic 
use, time spent in PACU, time spent in phase 2, total time from end of surgery to discharge from surgery 
center, and postoperative complications.  
 
 
Outcome 
Statistical Descriptor 
Statistical Test 
Primary outcome: 
Total opioid at 24 
hours (ME) 
Average 
t-test 
Secondary outcomes: 
QOR- 40 Score POD 
1 
Average 
t-test 
Pain score POD 1 
Average 
t-test 
Pain score at 1 week 
Average 
t-test 
Total opioid at 1 week 
(morphine 
equivalents) 
Average 
t-test 
Total antiemetic 
mediation used at 24 
hours 
Average 
t-test 
Total antiemetic 
mediation used at 1 
week 
Average 
t-test 
PONV 
Percentage 
Fisher’s exact test 
Complications 
Percentage 
Fisher’s exact test 
 
Data and Safety Monitoring Plan 
 
1. Summary of the Protocol: Please see the beginning of this protocol document for study design 
and procedures, as well as primary and secondary outcome measures. 
2. Roles and Responsibilities 
a. The principal investigator, Dr. Venkat Rao, will be responsible for monitoring the trial. 
Dr. Rao is a Professor of Surgery and the study is taking place under his supervision. Any 
adverse events will be reviewed promptly and reported to the IRB per current guidelines.  
b. Resident Physicians &/or future study team members who may assume a study 
coordinator role in the Department of Plastic Surgery, will be responsible for monitoring 
data collection, adverse events, and protocol deviations. Reportable events will be 
submitted per current guidelines. 
3. Data and events to be captured 
a. Study members will be collecting basic demographic information via chart review on all 
patients enrolled in this study. This will include patient age, BMI, medical comorbidities, 
smoking status, history of PONV. 
b. Study members will also be collecting data during the peri-operative period that is 
pertinent to the study. This will include time in each phase of care, total opioid use in 
PACU, survey results from PACU, POD 1 and POD 7. 


c. All adverse events, complications related to the procedure(s) performed as part of the 
study, deviations from the protocol will also be collected.  
4. Data Management, Analysis, and Quality Assurance: 
a. Identification of data sources (e.g., questionnaires, medical records, biospecimen 
collections, audio/video recordings) 
i. Data sources for this study include: 
1. Medical record review 
2. Questionnaires 
3. Postoperative diaries 
b. Frequency of Data Analysis 
i. For each group studied, study members will evaluate for complications due to 
study participation approximately every 15 patients that complete the study. This 
will allow for evaluation of safety while the study is taking place.   
c. Description of the security measures in place to protect data sources including how the 
data will be labeled and stored. 
i. To protect against and minimize potential risks to confidentiality, all the 
information collected in this study will be coded and data will be kept in a locked 
office on a secure password-protected Department of Surgery server backed up 
by Surgery’s internal IT team at the University of Wisconsin Hospital and Clinics 
Clinical Science Center. Hard copies of the consent forms will be stored in a 
filing cabinet in a locked office at the University of Wisconsin Hospital and 
Clinics Clinical Science Center. The information will only be made available to 
the study team members directly involved in the study. Confidentiality will be 
maintained by assigning a number to all subjects. The research subject log 
linking the name and subject number will be stored separately from the data and 
only authorized personnel will have access to the subject log. The PI and study 
staff will be alert for any breach of confidentiality.  
5. Trial Safety: 
a. Description of any specific events that would preclude a participant from continuing the 
intervention 
i. All subjects will be given the opportunity to discontinue their participation in the 
study at any time.  
ii. Peri-operatively, all subjects will be monitored using the same clinical practice 
standards that are applied to all patients undergoing surgery at Madison Surgery 
Center. This includes monitoring for signs of local anesthetic toxicity, as well as 
complications of regional blocks.  
b. Description of the consent/assent procedures (e.g., by whom, how and under what 
conditions will a subject be consented). 
i. Once deemed eligible to participate in the study by the physician, if a patient 
expresses interest in participating in the trial, a study team member will review 
the ICF and obtain written informed consent prior to enrollment for participation 
in the study.  
ii. On the day of surgery, a study team member will ensure written informed 
consent was obtained and reviewed prior to procedure and participation in the 
study.  
c. Description of the mechanisms in place to protect subject privacy. 
i. Patient confidentiality will be ensured throughout the duration of this study. 
Discussing the protocol with the subject in a private room will help protect the 
subject’s privacy. The collection of sensitive information will be limited to the 
amount necessary to achieve the aims of the research. The hard copies of the 
consent forms will be stored in a locked filing cabinet at the University of 


Wisconsin Hospital and Clinics Clinical Science Center. Confidentiality will be 
maintained by assigning a subject number to all subjects. The research subject 
log linking the name and subject number will stored separately from the data, and 
only authorized personnel will have access to the subject log. 
d. Description of the process for the disclosure of any conflicts of interest that may 
potentially challenge participant safety or bias the data and how the conflict will be 
managed. 
i. If any conflicts of interest arise that may challenge safety or bias the data, they 
will be immediately brought to the attention of the PI. If it is the PI with the 
conflict of interest, the study will be discontinued. 
e. Description of the data security in place to protect the confidentiality of the data (e.g., 
password protected encrypted electronic records) and any limits to confidentiality. 
i. To protect against and minimize potential risks to confidentiality, all the 
information collected in this study will be coded and data will be kept in a locked 
office on a secure password-protected Department of Surgery server backed up 
by Surgery’s internal IT team at the University of Wisconsin Hospital and Clinics 
Clinical Science Center. Hard copies of the consent forms will be stored in a 
locked filing cabinet in a locked office at the University of Wisconsin Hospital 
and Clinics Clinical Science Center. The information will only be made available 
to the study team members directly involved in the study. Confidentiality will be 
maintained by assigning a number to all subjects, and all data will be coded. The 
research subject log linking the name and subject number will be stored 
separately from the data and only authorized personnel will have access to the 
subject log. The PI and study staff will monitor closely for any breach of 
confidentiality. 
6. Reportable Events: 
a. Description of the process and timelines (e.g., hours, days) for collecting and reporting 
Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Problems 
Involving Risks to Subjects or Others to appropriate monitoring and regulatory entities  
i. Adverse Events, Serious Adverse Events, and Unanticipated Problems will be 
brought to the attention of the PI via email or telephone call (with plan for 
telephone call if no confirmed response to email) when study members become 
aware. SAEs will be monitored for up to 30 days following initial procedure date, 
per current guidelines.  
1. There are few rare side effects of local anesthetic injection into 
abdominal wall and if they occur, an adverse event would be reported. 
a. These side effects are rare: 
i. Visceral damage due to inadvertent peritoneal puncture 
ii. Seizure 
iii. Ventricular arrhythmia 
iv. Transient femoral palsy 
v. Bleeding and infection at the site of injection 
vi. Hypotension 
vii. Injecting local anesthesia into the wrong area including a 
blood vessel, and/or the space around the lungs. 
viii. Nerve damage 
ix. Cardiac arrest 
b. Rare side effects associated with liposomal bupivacaine 
i. Methemoglobinemia 
ii. Temporary prolonged loss of sensation 
2. Regional anesthesia is commonly used modality for adjunctive analgesia 


and anesthesia in elective abdominoplasty surgery, and is commonly 
performed at Madison Surgery Center. The risks of local anesthetic 
injection and regional anesthesia are not unique to Madison Surgery 
Center all providers performing regional anesthesia have been 
specifically trained to do so. 
3. As injection of local anesthesia is commonly performed in 
abdominoplasty cases, any risks attributable to injection of the anesthesia 
alone are not unique to this study, as patients undergoing the same 
procedure outside the study would have the same risks.  
a. The act of randomization may cause a patient to receive a less 
beneficial pain management or recovery protocol. However since 
surgery is currently performed with and without local anesthetic, 
as well as with and without bupivacaine or liposomal 
bupivacaine, the risks are well within the standard risks of 
elective abdominoplasty surgery. 
7. Stopping Rules 
a. Upon evaluation of patient data as described above, if any statistically significant 
increase in morbidity or mortality (including hospital admission or ER evaluation for 
complications related to respiratory depression) is identified, study members will re-
evaluate all results. If it is determined that a statistically significant increase in morbidity 
or mortality is attributable to patient participation in either group, all patient recruitment 
will be halted and the IRB will be contacted via ARROW. The safety of continuing with 
the study will be further evaluated, and procession of study activities will be halted until 
IRB approval.  
 
Protocol References 
 
1.  
Morales R, Mentz H, Newall G, Patronella C, Masters O. Use of abdominal field block injections 
with liposomal bupivicaine to control postoperative pain after abdominoplasty. Aesthetic Surg J. 
2013;33(8):1148-1153. doi:10.1177/1090820X13510720 
2.  
The American Society for Aesthetic Plastic Surgery. Cosmetic (Aesthetic) Surgery National Data 
Bank: Statistics 2018. 
3.  
Hu D, Onel E, Singla N, Kramer WG, Hadzic A. Pharmacokinetic profile of liposome bupivacaine 
injection following a single administration at the surgical site. Clin Drug Investig. 2013;33(2):109-
115. doi:10.1007/s40261-012-0043-z 
4.  
Grant GJ, Barenholz Y, Bolotin EM, et al. A novel liposomal bupivacaine formulation to produce 
ultralong-acting analgesia. Anesthesiology. 2004;101(1):133-137. doi:10.1097/00000542-
200407000-00021 
5.  
Sforza M, Andjelkov K, Zaccheddu R, Nagi H, Colic M. Transversus abdominis plane block 
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