CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
(Bupivacaine Liposome Injectable Suspension) +1 moredrug
Likely dose
Standard Preparation 100mlfrom 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/NCT02682498
NCT02682498Phase 4Completed
CompareCT.gov

A Double Blind, Randomized Clinical Trial Comparing Postoperative Narcotic Usage in Patients Receiving Periarticular Liposomal Bupivicaine vs. Those Patients Receiving Standard Periarticular Joint Injections

University of California, Irvine·interventional·Posted Feb 15, 2016·Updated Jul 7, 2017

In Brief

A Phase 4 clinical trial evaluating (Bupivacaine Liposome Injectable Suspension) and Standard Preparation for Arthroplasty, Replacement, Knee. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This study seeks to determine whether a new sustained-release local anesthetic solution (Exparel - Liposomal Bupivacaine) injected into the soft tissues around the joint after surgery will decrease opioid consumption and adverse events in opioid-tolerant patients presenting for total knee arthroplasty. The research hypothesis is that the Exparel (study) group will use less opioid in the first 48 hours post-operatively than the control group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthroplasty, Replacement, Knee
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2016
Enrollment StartOct 1, 2013
Primary CompletionJul 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.4 years ago

Interventions

(Bupivacaine Liposome Injectable Suspension)drug

Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.

Standard Preparationdrug

A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.