Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07212114

Efficacy of EXPAREL vs. Bupivacaine

Led by Emory University · Updated on 2026-02-23

104

Participants Needed

1

Research Sites

193 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

P

Pacira Pharmaceuticals, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Efficacy of EXPAREL vs. Bupivacaine

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indicated to undergo unilateral total ankle arthroplasty
  • American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
  • Able to provide informed consent, follow study schedule, and complete assessments
  • Body Mass Index (BMI) between 18 and 40 kg/m2
Not Eligible

You will not qualify if you...

  • Allergy or intolerance to study medications (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs) without alternatives
  • Painful conditions requiring opioids post-dosing that could affect study results
  • History or suspicion of addiction or abuse of drugs, prescription medicines, or alcohol within 2 years
  • Uncontrolled psychiatric disorders interfering with participation
  • Currently pregnant, nursing, or planning pregnancy during the study
  • History of contralateral ankle arthroplasty within 1 year
  • Need for ankle arthroplasty due to failed prior ankle arthrodesis
  • Avascular necrosis of the talus
  • Undergoing revision total ankle arthroplasty
  • Significant medical diseases that contraindicate study participation (e.g., diabetic neuropathy, coagulation disorders, severe vascular disease, renal or liver dysfunction)
  • Chronic opioid use within 30 days before randomization (average 30 or more oral morphine equivalents per day)
  • Prisoners
  • Cognitive impairment or impaired decision-making capacity
  • Inability to communicate in English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK)

Atlanta, Georgia, United States, 30329

Actively Recruiting

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Research Team

S

Sameh Labib, MD, FAOA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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