CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 60 enrolled
Drug / intervention
Exparel Injectable Product +1 moredrug
Likely dose
Exparel Injectable Product 226 mgfrom 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/NCT03270514
NCT03270514Phase 3Completed
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Postoperative Analgesia After Cardiac Surgery - A Double-Blind, Prospective and Randomized Comparison of Wound Infiltration With Liposomal Bupivacaine and Bupivacaine Hydrochloride

Kathirvel Subramaniam·interventional·Posted Sep 1, 2017·Updated Sep 5, 2021

In Brief

A Phase 3 clinical trial evaluating Exparel Injectable Product and Bupivacaine Hydrochloride for Coronary Artery Disease and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
CountriesUnited States
CollaboratorsPacira Pharmaceuticals, Inc

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedSep 1, 2017
Enrollment StartNov 15, 2018
Primary CompletionDec 13, 2019
Study CompletionFeb 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.8 years ago

Interventions

Exparel Injectable Productdrug

Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)

Bupivacaine Hydrochloridedrug

Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)