Efficacy of EXPAREL vs. Bupivacaine

ConditionsTotal Ankle Arthroplasty Postsurgical Analgesia

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorEmory University

About this trial

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

Eligibility criteria

Qualifiers

Indicated to undergo unilateral total ankle arthroplasty

American Society of Anesthesiologists (ASA) physical status 1, 2, or 3

Able to provide informed consent, adhere to the study schedule, and complete all study assessments

Body Mass Index (BMI) ≥18 and ≤40 kg/m2

Disqualifiers

Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)

Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-dosing period for pain, and which, in the Investigator's opinion, may confound the post-dosing assessments

History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years

Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance

Trial design

Treatments tested in this trial

EXPAREL
0.25% bupivacaine (HCl): 50 ml
0.25% bupivacaine (HCl): 30 ml

Treatment groups

104 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

Pacira Pharmaceuticals, Inc

Collaborator

Source ClinicalTrials.gov