CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Liposomal bupivacaine +1 moredrug
Likely dose
Liposomal bupivacaine 20mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03700970
NCT03700970Phase 4Completed
CompareCT.gov

Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction

Vanderbilt University Medical Center·interventional·Posted Oct 9, 2018·Updated Jan 24, 2022

In Brief

A Phase 4 clinical trial evaluating Liposomal bupivacaine and Regular bupivacaine for Breast Reconstruction and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Reconstruction, Anesthesia, Transverse Abdominis Plane Block
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 9, 2018
Enrollment StartJun 13, 2019
Primary CompletionMar 15, 2021
Study CompletionMar 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.7 years ago

Interventions

Liposomal bupivacainedrug

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 bupivacainedrug

20mL of 0.25% bupivacaine injected on each side.