Last updated on June 2018

Efficacy Safety and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery

Brief description of study

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in approximately 120 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia

Detailed Study Description

On Day 0, eligible subjects will be randomized in a 1:1 ratio to receive a single dose of EXPAREL 133 mg in 10 mL expanded in volume with 10 mL of normal saline for a total volume of 20 mL or placebo 20 mL. Study drug (EXPAREL or placebo) will be administered in a blinded manner via an ultrasound guided single-dose brachial plexus block at least 1 hour prior to surgery.

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; 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 is signed through postsurgical Day 29.

Follow-up visits will be scheduled for all subjects on postsurgical Days 5 and 10. A follow-up phone call will be made on postsurgical Day 29.

A population Pharmacokinetic (PK) analysis will be utilized to limit the number of blood draws with a sampling schedule of baseline (prior to the nerve block) through hospital discharge. There will be two collection sequences for this study and a subject can only be randomized to one sequence.

Clinical Study Identifier: NCT02713230

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Hassan Danesi

Brookwood Medical Center
Birmingham, AL United States

Robert Calin, MD

Horizon Research Group, Inc
Mobile, 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

Jeffrey Gadsden, MD

Duke University Medical Center
Raleigh-Durham, NC United States

Sabry Ayad, MD

Fairview Hospital
Cleveland, OH United States

David Bizousky, MD

Indiana Regional Medical Center
Indiana, PA United States

Eugene 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

Julie Greene, MD

Plano Surgical Hospital
Plano, TX United States

Harold Adams

Houston Physician's Hospital
Webster, TX United States

Manish Patel, MD

Southampton Orthopedics Sports Medicine
Franklin, VA United States

Sam Van Boxstael, MD

Ziekenhuis Oost-Limburg
Genk, Belgium

Thomas Fichtner Bendtsen, MD

Aarhus University Hospital
Aarhus, Denmark

Jens Rolighed Larsen, MD

Regionshospital Silkeborg
Silkeborg, Denmark

Boleslav Kosharskyy, MD

Montefiore Medical Center
The Bronx, NY United States