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Efficacy of EXPAREL vs. Bupivacaine

NCT07212114 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-02-23

No results posted yet for this study

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

Conditions

  • Total Ankle Arthroplasty
  • Postsurgical Analgesia

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

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Sameh Labib, MD, FAOA · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2029-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212114 on ClinicalTrials.gov