Phase 3 Adductor Canal Block With EXPAREL in Subjects Undergoing Primary Unilateral Total Knee Arthroplasty

NCT05139030 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 402-C-335
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of the study is to compare magnitude of postsurgical analgesic effect in different groups following a single dose of study drug when administered via adductor canal block in subjects undergoing primary unilateral total knee arthroplasty.

Conditions

Knee Osteoarthritis; Pain Management

Keywords

EXPAREL; bupivacaine; analgesic; Adductor Canal Block; TKA; knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• NRS 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 to 96 hours post-surgery

Secondary Outcomes (3)

• Postsurgical Opioid Consumption Through 96 Hours Post-surgery

  0 to 96 hours post-surgery

• Time to First Opioid

  0 to 96 hours post-surgery

• NRS Scores

  0-24hours, 24-48hours, 48-72hours, 72-96hours

Study Arms (4)

Cohort 1: EXPAREL admix arm

EXPERIMENTAL

subjects randomized to this treatment arm will receive 10 mL (133 mg) EXPAREL admixed with 10 mL (50 mg) 0.5% bupivacaine HCl

Drug: bupivacaine liposome injectable suspension

Cohort 1: Bupivacaine HCl arm

ACTIVE COMPARATOR

subjects randomized to this treatment arm will receive 10 mL (50 mg) 0.5% bupivacaine HCl mixed with 10 mL normal saline

Drug: Bupivacaine Hydrochloride

Cohort 2: EXPAREL admix arm

EXPERIMENTAL

subjects randomized to this treatment arm will receive 10 mL (133 mg) EXPAREL admixed with 10 mL (50 mg) 0.5% bupivacaine HCl

Drug: bupivacaine liposome injectable suspension

Cohort 2: Bupivacaine HCl arm

ACTIVE COMPARATOR

subjects randomized to this treatment arm will receive 10 mL (50 mg) 0.5% bupivacaine HCl mixed with 10 mL normal saline

Drug: Bupivacaine Hydrochloride

Interventions

bupivacaine liposome injectable suspension DRUG

Adductor canal block with EXPAREL

Also known as: EXPAREL

Cohort 1: EXPAREL admix arm; Cohort 2: EXPAREL admix arm

Bupivacaine Hydrochloride DRUG

Adductor Canal Block with bupivacaine HCl

Cohort 1: Bupivacaine HCl arm; Cohort 2: Bupivacaine HCl 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.
• Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia.
• Primary indication for TKA is degenerative osteoarthritis of the knee.
• 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).
• Planned concurrent surgical procedure (e.g., bilateral TKA).
• Undergoing unicompartmental TKA or revision TKA.
• 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 knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments.
• Inadequate sensory function below the knee as assessed by the Investigator.
• History of contralateral TKA within 1 year.
• Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted.
• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (6)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Lotus Clinical Research

Pasadena, California, 91105, United States

Location

Midwest Clinical Research Center, LLC

Dayton, Ohio, 45417, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

HD Research- Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

Location

Related Publications (1)

• Gadsden J, Gonzales J, Saha P. Plain language summary of a pain medication (liposomal bupivacaine) for pain relief after knee replacement surgery. Pain Manag. 2025 Dec 19:1-10. doi: 10.1080/17581869.2025.2592701. Online ahead of print.

  PMID: 41416686 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic 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: Only study drug administrators (anesthesiologists) will be unblinded to perform the block procedures
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 1, 2021
• Study Start: January 18, 2022
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)