Recruiting
Phase 3

EXPAREL vs. Bupivacaine

Sponsor:

Emory University

Code:

NCT07212114

Conditions

Total Ankle Arthroplasty

Postsurgical Analgesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EXPAREL

0.25% bupivacaine (HCl): 50 ml

0.25% bupivacaine (HCl): 30 ml

Study Details

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

Study ID

NCT07212114

Start date

Nov 17, 2025

Status verified date

Feb, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Admix

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)

experimental: Reference

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)

Interventions

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.

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)

0.25% bupivacaine (HCl): 30 ml

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

Primary outcome measure

  • Magnitude of the analgesic effect [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Sameh Labib, MD, FAOA

404-778-4398slabib@emory.edu

Locations

Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK)

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Sameh Labid, MD, FAOA

404-778-4398slabib@emory.edu

More Information

Sponsor

Emory University

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Pain management
  • Postsurgical Analgesia
  • Bupivacaine
  • EXPAREL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-02-23.