At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 23 enrolled

Drug / intervention

Bupivacaine FNB +1 moredrug

Likely dose

Bupivacaine FNB 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/NCT02255500

NCT02255500Phase 4Completed

Compare CT.gov

Evaluation of the Pharmacokinetics and Safety of Local Administration of EXPAREL in Subjects Undergoing Femoral Nerve Block With Bupivacaine HCl for Unilateral Total Knee Arthroplasty

Pacira Pharmaceuticals, Inc·interventional·Posted Oct 2, 2014·Updated Mar 8, 2021

In Brief

A Phase 4 clinical trial evaluating Bupivacaine FNB and EXPAREL Infiltration for Pain. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of EXPAREL in subjects who undergo femoral nerve block with bupivacaine HCl for unilateral total knee arthroplasty (TKA).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPain

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartSep 2014

First PostedOct 2014

Primary CompletionMar 2015

TodayJul 2026

First PostedOct 2, 2014

Enrollment StartSep 1, 2014

Primary CompletionMar 1, 2015

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 11.8 years ago

Interventions

Bupivacaine FNBdrug

A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.

EXPAREL Infiltrationdrug

A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.