Optimizing Recovery in Abdominoplasty

Randomized Controlled Trial Evaluating Liposomal Bupivacaine Following Abdominoplasty

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Liposomal bupivacaine; Other: Standard of care

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Madison
    • Madison, Wisconsin, United States, 53715
      • University of Wisconsin Madison Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Medically cleared to undergo elective surgery (including associated anesthesia) at UW Madison Surgery Center (MSC).

Exclusion Criteria:

• Pregnant or breast-feeding women
• Incarcerated women or men
• Individuals unable to give consent due to another condition such as impaired decision-making capacity.
• Men or women who take opioid pain medications on a regular basis prior to surgery
• Men or women with a history of opioid abuse and/or dependence
• Participants with a history of bleeding disorders precluding safe abdominoplasty
• Participants on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist
• Participants not medically cleared for surgery at Madison Surgery Center. This would include participants with sepsis/bacteremia, significant valvular disorders or heart conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liposomal Bupivacaine; Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.	Drug: Liposomal bupivacaine; Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.
Other: Bupivacaine; Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.	Other: Standard of care; Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use at 24 Hours	Amount of opioids used postoperatively, measured in morphine equivalents	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery-40 (QOR-40) Score	The QOR-40 is a 40 item survey about the quality of recovery with a total possible range of scores from 40 to 200 where the higher the score the higher quality the recovery.	24 hours postoperatively
Pain Score Postoperative Day 1 (POD 1)	The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.	24 hours postoperatively
Pain Score 1 Week Postop	The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.	1 week postoperatively
Opioid Use at 1 Week	total opioid used, measure in morphine equivalents	1 week postoperatively
Antiemetic Use POD 1	total antiemetic used	24 hours postoperatively
Antiemetic Use 1 Week	total antiemetic used	1 week postoperatively
Number of Participants With Postoperative Nausea and Vomiting		24 hours postoperatively
Number of Participants With Postoperative Complications		1 week postoperatively

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Venkat Rao, MD, MBA, University of Wisconsin Hospitals and Clinics

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2021
• Primary Completion (Actual): January 21, 2021
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: abdominoplasty; Liposomal bupivacaine; enhanced recovery after surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 2019-1570; A539730 (Other Identifier: UW- Madison); SMPH/SURGERY/DENTL-PLASTC SRGY (Other Identifier: UW Madison); Protocol Ver 2, 04/09/2021 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No