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

Contact Investigators or Research Sites near you

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Brookwood Medical Center

Birmingham, AL United States

Horizon Research Group, Inc

Mobile, AL United States

Denver Metro Orthopedics

Englewood, CO United States

Shrock Orthopedic Research

Fort Lauderdale, FL United States

Pensacola Research Associates

Pensacola, FL United States

Brigham and Women's Hospital

Boston, MA United States

Massachusetts General Hospital

Boston, MA United States

Stony Brook Medicine

Stony Brook, NY United States

Duke University Medical Center

Raleigh-Durham, NC United States

Fairview Hospital

Cleveland, OH United States

Indiana Regional Medical Center

Indiana, PA United States

Thomas Jefferson University Hospital

Philadelphia, PA United States

Hermann Drive Surgical Hospital

Houston, TX United States

Westside Surgical Hospital

Houston, TX United States

Plano Surgical Hospital

Plano, TX United States

Houston Physician's Hospital

Webster, TX United States

Southampton Orthopedics Sports Medicine

Franklin, VA United States

Ziekenhuis Oost-Limburg

Genk, Belgium

Aarhus University Hospital

Aarhus, Denmark

Regionshospital Silkeborg

Silkeborg, Denmark

Montefiore Medical Center

The Bronx, NY United States

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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