CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 121 enrolled
Drug / intervention
Exparel +1 moredrug
Likely dose
Not stated in 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/NCT04518462
NCT04518462Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic (in Popliteal Fossa) and Saphenous (in Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries

Pacira Pharmaceuticals, Inc·interventional·Posted Aug 19, 2020·Updated Jul 18, 2022

In Brief

A Phase 3 clinical trial evaluating Exparel and Bupivacaine Hydrochloride for Lower Extremity Surgery and 5 related conditions. Completed, enrolled 121 participants across 5 sites.

Detailed Summary

This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion, Hindfoot Fushion, Total Ankle Arthroplasty
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedAug 19, 2020
Enrollment StartOct 20, 2020
Primary CompletionApr 5, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.9 years ago

Interventions

Expareldrug

EXPAREL (bupivacaine liposome injectable suspension)

Bupivacaine Hydrochloridedrug

0.25% bupivacaine