Efficacy of EXPAREL vs. Bupivacaine

NCT07212114 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: STUDY000086842025P010479
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain management; Postsurgical Analgesia; Bupivacaine; EXPAREL

Outcome Measures

Primary Outcomes (1)

• Magnitude of the analgesic effect

  To measure this, the Area under the curve (AUC) of the Numeric Rating Scale (NRS) for both groups will be compared. The subjects will be asked to rate their worst or average pain on a scale of 0 (no pain) - 10 (worst possible pain) on numerous time points, starting upon arrival in the Post-Anesthesia Care Unit (PACU)

  Perioperative (Upon arrival in the PACU (±5 min), Postoperative (At PACU discharge (±5 min)), Every 6 hours from the end of surgery until health care facility discharge up to 96h

Secondary Outcomes (9)

• Total opioid consumption

  Baseline (Hour 0), 96 hours post surgery

• Time to first opioid consumption

  Baseline (Hour 0), 96 hours post surgery

• Patient safety

  Baseline (Hour 0), Day 14 post op

• Subject satisfaction

  Within 96 hours post op

• Pain intensity: Numeric Rating Scale (NRS) Short term

  Every 6 hours from the end of surgery until health care facility discharge up to 96h

Study Arms (2)

Admix

EXPERIMENTAL

EXPAREL admixed with 0.25% bupivacaine HCl Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal)

Drug: EXPAREL; Drug: 0.25% bupivacaine (HCl): 30 ml

Reference

EXPERIMENTAL

Bupivacaine HCl arm Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal)

Drug: 0.25% bupivacaine (HCl): 50 ml

Interventions

EXPAREL DRUG

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.

Also known as: bupivacaine liposome injectable suspension

Admix

0.25% bupivacaine (HCl): 50 ml DRUG

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)

Reference

0.25% bupivacaine (HCl): 30 ml DRUG

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

Admix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Currently pregnant, nursing, or planning to become pregnant during the study
• History of contralateral ankle arthroplasty within 1 year
• Subjects that require ankle arthroplasty due to failed prior ankle arthrodesis
• Subjects with avascular necrosis of the talus
• Subjects undergoing revision total ankle arthroplasty
• Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study
• Chronic opioid use within 30 days before randomization (average ≥30 oral morphine equivalents/day
• Prisoners
• Cognitive impairment or impaired decision-making capacity
• Inability to communicate in English

Sponsors & Collaborators

• Emory University: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK)

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sameh Labib, MD, FAOA

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sameh Labib, MD, FAOA

CONTACT

404-778-4398; slabib@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: October 8, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available beginning 6 months after publication of the primary study results

Locations

US (1)