Last updated on February 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
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Robert Calin, MD

Horizon Research Group, Inc
Mobile, AL United States
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Timothy Melson, MD

Helen Keller Hospital
Sheffield, AL United States
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John Schwappach, MD

Denver Metro Orthopedics
Englewood, CO United States
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Kevin Shrock, MD

Shrock Orthopedic Research
Fort Lauderdale, FL United States
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Keith Candiotti, MD

Jackson Memorial Hospital/University of Miami
Miami, FL United States
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E J Dabezies, Jr., MD

Pensacola Research Associates
Pensacola, FL United States
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Srdjan Nedeljkovic, MD

Brigham and Women's Hospital
Boston, MA United States
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Srdjan Nedeljkovic, MD

Massachusetts General Hospital
Boston, MA United States
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Syed Azim, MD

Stony Brook Medicine
Stony Brook, NY United States
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Jeffery Gadsden, MD

Duke University Medical Center
Raleigh-Durham, NC United States
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David Bizousky, MD

Indiana Regional Medical Center
Indiana, PA United States
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Eugene R Viscusi, MD

Thomas Jefferson University Hospital
Philadelphia, PA United States
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David Leiman, MD

Hermann Drive Surgical Hospital
Houston, TX United States
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Harold Minkowitz, MD

Westside Surgical Hospital
Houston, TX United States
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Manish Patel, MD

Southampton Orthopaedics Sports Medicine
Franklin, VA United States
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Sam Van Boxstael, MD

Ziekenhuis Oost-Limburg
Genk, Belgium
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Thomas Fichtner Bendtsen, MD

Aarhus University Hospital
Aarhus C, Denmark
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Jens Rolighed Larsen, MD

Regionshospital Silkeborg
Silkeborg, Denmark
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Boleslav Kosharskyy, MD

Montefiore Medical Center
The Bronx, NY United States
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