NCT04254692

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2021

Shorter than P25 for phase_4 postoperative-pain

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

January 5, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2021

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

July 1, 2024

Enrollment Period

16 days

First QC Date

December 23, 2019

Results QC Date

June 20, 2024

Last Update Submit

July 16, 2024

Conditions

Postoperative Pain

Keywords

abdominoplastyenhanced recovery after surgeryLiposomal bupivacaine

Outcome Measures

Primary Outcomes (1)

  • Opioid Use at 24 Hours

    Amount of opioids used postoperatively, measured in morphine equivalents

    24 hours postoperatively

Secondary Outcomes (8)

  • Quality of Recovery-40 (QOR-40) Score

    24 hours postoperatively

  • Pain Score Postoperative Day 1 (POD 1)

    24 hours postoperatively

  • Pain Score 1 Week Postop

    1 week postoperatively

  • Opioid Use at 1 Week

    1 week postoperatively

  • Antiemetic Use POD 1

    24 hours postoperatively

  • +3 more secondary outcomes

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

Participants in this study arm will receive intraoperative injection of Liposomal Bupivacaine mixed with Bupivacaine to the abdominal wall.

Drug: Liposomal bupivacaine

Bupivacaine

OTHER

Participants in this study arm will receive intraoperative injection of bupivacaine without Liposomal bupivacaine to the abdominal wall.

Other: Standard of care

Interventions

Liposomal bupivacaineDRUG

Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.

Liposomal Bupivacaine
Standard of careOTHER

Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall

Bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Wisconsin Madison Surgery Center

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

study terminated early, not powered for meaningful results

Results Point of Contact

Title
Venkat Rao, MD, MBA
Organization
University of Wisconsin School of Medicine and Public Health
rao@surgery.wisc.edu
(608) 263-1223

Study Officials

  • Venkat Rao, MD, MBA

    University of Wisconsin Hospitals and Clinics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2019

First Posted

February 5, 2020

Study Start

January 5, 2021

Primary Completion

January 21, 2021

Study Completion

January 21, 2021

Last Updated

August 7, 2024

Results First Posted

August 7, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)