Trial Outcomes & Findings for Optimizing Recovery in Abdominoplasty (NCT NCT04254692)

NCT ID: NCT04254692

Last Updated: 2024-08-07

Results Overview

Amount of opioids used postoperatively, measured in morphine equivalents

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 2 participants
• Primary outcome timeframe: 24 hours postoperatively
• Results posted on: 2024-08-07

Participant Flow

Data collection occurred from 1/5/2021 to 1/21/2021

Participant milestones

Measure	Liposomal Bupivacaine Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall	Total n=2 Participants Total of all reporting groups
Age, Continuous	54 years n=1 Participants	35 years n=1 Participants	45.1 years n=2 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=2 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	1 participants n=1 Participants	2 participants n=2 Participants
Body Mass Index (BMI)	25.8 kilograms per meter squared n=1 Participants	19.1 kilograms per meter squared n=1 Participants	22.5 kilograms per meter squared n=2 Participants

PRIMARY outcome

Timeframe: 24 hours postoperatively

Amount of opioids used postoperatively, measured in morphine equivalents

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Opioid Use at 24 Hours	0 morphine milligram equivalents	15 morphine milligram equivalents

SECONDARY outcome

Timeframe: 24 hours postoperatively

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.

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Quality of Recovery-40 (QOR-40) Score	161 score on a scale	168 score on a scale

SECONDARY outcome

Timeframe: 24 hours postoperatively

The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Pain Score Postoperative Day 1 (POD 1)	6.5 score on a scale	8 score on a scale

SECONDARY outcome

Timeframe: 1 week postoperatively

The pain survey is scored on a 0-10 scale where 0 is no pain and 10 is the worst possible pain.

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Pain Score 1 Week Postop	2 score on a scale	1 score on a scale

SECONDARY outcome

Timeframe: 1 week postoperatively

total opioid used, measure in morphine equivalents

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Opioid Use at 1 Week	0 morphine milligram equivalents	0 morphine milligram equivalents

SECONDARY outcome

Timeframe: 24 hours postoperatively

total antiemetic used

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Antiemetic Use POD 1	0 antiemetic doses	0 antiemetic doses

SECONDARY outcome

Timeframe: 1 week postoperatively

total antiemetic used

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Antiemetic Use 1 Week	0 antiemetic doses	0 antiemetic doses

SECONDARY outcome

Timeframe: 24 hours postoperatively

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Number of Participants With Postoperative Nausea and Vomiting	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 week postoperatively

Outcome measures

Measure	Liposomal Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall. Liposomal bupivacaine: Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.	Bupivacaine n=1 Participants Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall. Standard of care: Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
Number of Participants With Postoperative Complications	0 Participants	0 Participants

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Venkat Rao, MD, MBA

University of Wisconsin School of Medicine and Public Health

Phone: (608) 263-1223

Email: rao@surgery.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place