CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
Liposomal Bupivacaine +2 moredrug
Likely dose
Liposomal Bupivacaine 266mgfrom 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/NCT03001453
NCT03001453Phase 2Completed

Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine.

American Hip Institute·interventional·Posted Dec 23, 2016·Updated Jul 26, 2018

In Brief

A Phase 2 clinical trial evaluating Liposomal Bupivacaine, 0.25% Bupivacaine with epinephrine, and 1 other intervention for Pain, Postoperative. Completed, enrolled 107 participants across 2 sites.

Detailed Summary

The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 23, 2016
Enrollment StartApr 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.5 years ago

Interventions

Liposomal Bupivacainedrug

266mg liposomal bupivacaine

0.25% Bupivacaine with epinephrinedrug

0.25% bupivacaine with epinephrine

Salinedrug

Normal saline