Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy

NCT05157841 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 402-C-334
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 7

Brief Summary

The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg EXPAREL. Part B: The purpose is to evaluate the efficacy and safety of the preferred dosage of EXPAREL from Part A compared with bupivacaine HCl.

Conditions

Bunionectomy; Hallux Valgus

Keywords

EXPAREL; Bupivacaine; Analgesia

Outcome Measures

Primary Outcomes (1)

• NRS Pain Scores Through 96 Hours Post-surgery

  The numeric rating scale pain intensity scores ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 96 hours post-surgery. For each subject, the area under the curve was derived using the trapezoidal rule on the pain scores adjusted for opioid pain medication using the observed and imputed values. Area under the curve started with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 96 hours post-surgery. Pain scores were taken at 5 interval point 0 hours, 24 hours, 48 hours, 72 hours, and 96 hours. There were also unscheduled pain scores measured before opioid consumption also included in the area under the curve calculation. The area under the curve ranged from 0 to 960. Higher scores represent a worse outcome.

  0- 96 hours post-surgery

Secondary Outcomes (4)

• Postsurgical Opioid Consumption Through 96 Hours Post-surgery

  0 to 96 hours post-surgery

• Opioid-free Subjects Through 96 Hours Post-surgery

  0 to 96 hours post-surgery

• First Opioid Consumption Post-surgery

  0 to 96 hours post-surgery

• NRS Pain Scores Post-surgery

  0-24 hours, 24-48 hours, 48-72 hours, and 72-96 hours post-surgery

Study Arms (5)

Part A: EXPAREL 266 mg arm

EXPERIMENTAL

subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 10 mL saline

Drug: Bupivacaine liposome injectable suspension 266 mg

Part A: EXPAREL 133 mg arm

EXPERIMENTAL

subjects randomized to this treatment arm will receive 10 mL (133 mg) EXPAREL mixed with 20 mL saline

Drug: Bupivacaine liposome injectable suspension 133 mg

Part A: Bupivacaine HCl arm

ACTIVE COMPARATOR

Subjects randomized to this treatment arm will receive 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline

Drug: Bupivacaine HCl

Part B: EXPAREL 133 mg arm OR EXPAREL 266 mg arm

EXPERIMENTAL

Subjects randomized to this treatment arm will receive 20 mL (266 mg) EXPAREL mixed with 10 mL saline OR 10 mL (133 mg) EXPAREL mixed with 20 mL saline. Dose will be determined following interim analysis of Part A.

Drug: Bupivacaine liposome injectable suspension 133 mg

Part B: Bupivacaine HCl arm

ACTIVE COMPARATOR

subjects randomized to this treatment arm will receive 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline

Drug: Bupivacaine HCl

Interventions

Bupivacaine liposome injectable suspension 266 mg DRUG

Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg

Also known as: EXPAREL

Part A: EXPAREL 266 mg arm

Bupivacaine HCl DRUG

Sciatic nerve block in the popliteal fossa with Bupivacaine HCl

Part A: Bupivacaine HCl arm; Part B: Bupivacaine HCl arm

Bupivacaine liposome injectable suspension 133 mg DRUG

Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg

Also known as: EXPAREL

Part A: EXPAREL 133 mg arm; Part B: EXPAREL 133 mg arm OR EXPAREL 266 mg arm

Eligibility Criteria

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

You may qualify if:

• Male or female, ages 18 or older at screening
• 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
• Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a distal metaphyseal osteotomy procedure (e.g., Austin procedure as opposed to Lapiplasty, Lapidus bunionectomies or base wedge bunionectomies)
• Indicated to undergo elective (i.e., not emergency) bunionectomy
• 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 (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the foot surgery and which, in the Investigator's opinion, may confound the post dosing assessments
• Inadequate sensory function of the foot/ankle as assessed by the Investigator
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
• Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
• Previous participation in an EXPAREL study
• 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
• 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
• Currently on a neuromodulating agent (e.g., gabapentin, pregabalin \[Lyrica\], duloxetine \[Cymbalta\], etc.)
• Current use of systemic glucocorticoids within 30 days of randomization in this study
• Use of dexmedetomidine HCl (Precedex®) or clonidine within 3 days of study drug administration
• Any use of marijuana (including tetrahydrocannabinol (THC) and cannabidiol (CBD)) within 30 days prior to randomization, or planned use during the course of the study
• Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (7)

Arkansas Surgical Hospital

North Little Rock, Arkansas, 72118, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

HD Research- First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

HD Research-Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

Houston Heights Hospital

Houston, Texas, 77008, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Related Publications (1)

• Schwartz G, Gadsden JC, Gonzales J, Hutchins J, Song J, Brady O, DiGiorgi M, Winston R. A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy. J Clin Anesth. 2024 Jun;94:111402. doi: 10.1016/j.jclinane.2024.111402. Epub 2024 Feb 9.

  PMID: 38340677 DERIVED

MeSH Terms

Conditions

Hallux Valgus; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; 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

Results Point of Contact

• Title: Pacira Medical Information
• Organization: Pacira Pharmaceuticals, Inc.

MedInfo@pacira.com

1-855-793-9727

Study Officials

• Gary Nevins

  Pacira Pharmaceuticals, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Individuals preparing and administering study drug, or transporting unblinded drug will not be allowed to perform any of the study assessments after randomization (with the possible logistical exception of drawing blood in the operating room (OR) to be processed by blinded staff for the PK assessments) or reveal the assigned study treatment to any other members of the study team at any time. Additionally, efforts will be made to prevent the subject from observing the study drug syringe. Staff members conducting study-specific, postsurgical assessments and the subjects will remain blinded to the assigned treatment throughout the study in part by not being present during the administration of the nerve block. The site PI must be blinded to the study drug and will not be involved in and/or present during study drug administration. No crossover will be permitted between the blinded and unblinded study personnel throughout the study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 15, 2021
• Study Start: February 15, 2022
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)