CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Liposomal bupivacainedrug
Likely dose
Liposomal bupivacaine 20 mLfrom 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/NCT02349542
NCT02349542Phase 4Completed
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The Safety of Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty

OrthoCarolina Research Institute, Inc.·interventional·Posted Jan 29, 2015·Updated Aug 31, 2017

In Brief

A Phase 4 clinical trial evaluating Liposomal bupivacaine for Arthroplasty, Replacement, Knee and Pain. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the serum levels (pharmacokinetics) of bupivacaine in a series of patients undergoing simultaneous bilateral total knee arthroplasty with the use of a standardized periarticular injection containing free bupivacaine and liposomal bupivacaine.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 29, 2015
Enrollment StartJan 1, 2015
Primary CompletionNov 1, 2016
Study CompletionNov 21, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.4 years ago

Interventions

Liposomal bupivacainedrug

One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (\~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.