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RECRUITING
NCT07212114
PHASE3

Efficacy of EXPAREL vs. Bupivacaine

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl). Secondary objectives are to: Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl * Compare the time to first opioid consumption following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl * Assess the safety of EXPAREL vs. 0.25% bupivacaine HCl * Evaluate subject satisfaction with pain management following a single-dose injection of EXPAREL vs. 0.25% bupivacaine hydrochloride (HCl) * Compare clinical performance from Preoperative status to 3- and 12- months postoperatively

Official title: A Randomized, Double-blind, Active Controlled, Single-center Study to Evaluate the Efficacy of EXPAREL vs. Bupivacaine HCl Administered as Combined Sciatic (in the Popliteal Fossa) and Saphenous (in the Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Total Ankle Arthroplasty

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2025-11-17

Completion Date

2029-08

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

EXPAREL

EXPAREL (bupivacaine liposome injectable suspension) is formulated as a sterile, non-pyrogenic, white to off-white, preservative-free homogenous suspension of bupivacaine encapsulated into multivesicular liposomes (pMVL drug delivery system). For this study, EXPAREL will be provided in 20 mL (266 mg) EXPAREL single-use, clear glass vials.

DRUG

0.25% bupivacaine (HCl): 50 ml

The reference product is 50 mL (100 mg) 0.25% bupivacaine HCl administered via a combined sciatic (in the popliteal fossa) and saphenous nerve block (in the adductor canal)

DRUG

0.25% bupivacaine (HCl): 30 ml

EXPAREL admixed with 30 mL (75 mg) 0.25% bupivacaine HCl

Locations (1)

Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK)

Atlanta, Georgia, United States