CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 15 enrolled
Drug / intervention
Bupivacaine SNB +1 moredrug
Likely dose
Bupivacaine SNB 1.6 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/NCT02284386
NCT02284386Phase 4Completed
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Evaluation of the Pharmacokinetics and Safety of Bupivacaine HCl Spinal Block and EXPAREL Local Infiltration in Subjects Undergoing for Unilateral Total Knee Arthroplasty

Pacira Pharmaceuticals, Inc·interventional·Posted Nov 6, 2014·Updated Mar 8, 2021

In Brief

A Phase 4 clinical trial evaluating Bupivacaine SNB and EXPAREL Infiltration for Pain. Completed, enrolled 15 participants across 2 sites.

Detailed Summary

This is a Phase 4, multicenter, open-label study designed to characterize the pharmacokinetic (PK) profile of total bupivacaine in approximately 15 adult subjects undergoing primary unilateral total knee arthroplasty (TKA) with bupivacaine hydrochloride (HCl) spinal nerve block (SNB) and EXPAREL local infiltration into the surgical site.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 6, 2014
Enrollment StartDec 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.7 years ago

Interventions

Bupivacaine SNBdrug

SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.

EXPAREL Infiltrationdrug

Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.