Last updated on June 2018

Efficacy Safety and Pharmacokinetics of Femoral Nerve Block With EXPAREL in Total Knee Arthroplasty


Brief description of study

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in approximately 300 adult subjects undergoing primary unilateral TKA under general or spinal anesthesia.

Detailed Study Description

On Day 0, eligible subjects will be randomized in a 1:1:1 ratio to receive a single dose of either EXPAREL 133 mg in 10 mL expanded in volume with 10 mL of normal saline for a total volume of 20 mL (Group 1); EXPAREL 266 mg in 20 mL (Group 2); or placebo 20 mL (Group 3). Study drug (EXPAREL or placebo) will be administered in a blinded manner via an ultrasound guided single-dose femoral nerve block at least 1 hour prior to surgery. Prior to placement of the prosthesis, 8 mL of bupivacaine hydrochloride (HCl) (0.5%) diluted with 8 mL of normal saline will be administered by the surgeon as a periarticular infiltration to the posterior capsule (8 mL medially and 8 mL laterally).

Postsurgical assessments will include pain intensity scores using a 10-cm visual analog scale (VAS); total postsurgical opioid consumption; overall benefit of analgesia score (OBAS) questionnaire; subject satisfaction with overall analgesia using a 5-point Likert scale; neurological assessment; sensory function assessment; motor function assessment; the study physical therapy assessments (ie, timed walk, timed up and go, and stair climbing tests); discharge readiness; unscheduled phone calls or office visits related to pain; 12-lead ECGs; vital sign measurements; and clinical laboratory tests. Adverse events will be recorded from the time the informed consent form (ICF) is signed through postsurgical Day 29.

Follow-up visits will be scheduled for all subjects on postsurgical Days 6 and 10. A follow-up phone call will be made on postsurgical Day 29.

Pharmacokinetic (PK) parameters will be estimated from plasma bupivacaine measurements using non-compartmental analysis based on the sampling schedule of baseline (prior to the nerve block) through postsurgical Day 10.

Clinical Study Identifier: NCT02713178

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Robert Sorrell, MD

Brookwood Medical Center
Birmingham, AL United States

Robert Calin, MD

Horizon Research Group, Inc
Mobile, AL United States

Timothy Melson, MD

Helen Keller Hospital
Sheffield, AL United States

John Schwappach, MD

Denver Metro Orthopedics
Englewood, CO United States

Kevin Shrock, MD

Shrock Orthopedic Research
Fort Lauderdale, FL United States

Keith Candiotti, MD

Jackson Memorial Hospital/University of Miami
Miami, FL United States

E J Dabezies, Jr., MD

Pensacola Research Associates
Pensacola, FL United States

Srdjan Nedeljkovic, MD

Brigham and Women's Hospital
Boston, MA United States

Srdjan Nedeljkovic, MD

Massachusetts General Hospital
Boston, MA United States

Syed Azim, MD

Stony Brook Medicine
Stony Brook, NY United States

Jeffery Gadsden, MD

Duke University Medical Center
Raleigh-Durham, NC United States

David Bizousky, MD

Indiana Regional Medical Center
Indiana, PA United States

Eugene R Viscusi, MD

Thomas Jefferson University Hospital
Philadelphia, PA United States

David Leiman, MD

Hermann Drive Surgical Hospital
Houston, TX United States

Harold Minkowitz, MD

Westside Surgical Hospital
Houston, TX United States

Manish Patel, MD

Southampton Orthopaedics Sports Medicine
Franklin, VA United States

Sam Van Boxstael, MD

Ziekenhuis Oost-Limburg
Genk, Belgium

Thomas Fichtner Bendtsen, MD

Aarhus University Hospital
Aarhus C, Denmark

Jens Rolighed Larsen, MD

Regionshospital Silkeborg
Silkeborg, Denmark

Boleslav Kosharskyy, MD

Montefiore Medical Center
The Bronx, NY United States