CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Depofoam bupivacaine +1 moredrug
Likely dose
Not stated in 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/NCT04278846
NCT04278846Phase 4Completed
CompareCT.gov

Efficacy of Liposomal Bupivacaine for Prolonged Postoperative Analgesia in Patient Undergoing Breast Reconstruction With Tissue Expander

The Cleveland Clinic·interventional·Posted Feb 20, 2020·Updated Jul 1, 2022

In Brief

A Phase 4 clinical trial evaluating Depofoam bupivacaine and Bupivacaine hydrochloride (HCl) for Pain, Postoperative and Mammaplasty. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Patients undergoing breast reconstruction with tissue expanders will be treated with a local anesthetic during their procedure and monitor their post-operative pain level and amount of oral pain medication taken. This information will be used to determine if liposomal bupivacaine provides better and longer pain control vs. bupivacaine HCl.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative, Mammaplasty
CountriesUnited States
CollaboratorsPacira Pharmaceuticals, Inc

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2020
Enrollment StartAug 22, 2014
Primary CompletionDec 31, 2017
Study CompletionMay 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.4 years ago

Interventions

Depofoam bupivacainedrug

The study drug Depofoam bupivacaine will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.

Bupivacaine hydrochloride (HCl)drug

The study drug bupivacaine HCl will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.