This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline
20 mL EXPAREL (bupivacaine liposome injectable suspension)
20 mL normal saline as single-injection
Horizon Research Group, Inc
Mobile, Alabama, United States
Denver Metro Orthopedics
Englewood, Colorado, United States
Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores
AUC of VAS pain intensity scores through 48 hours, which represents total pain experienced through 48 hours. VAS is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now."
Time frame: 0-48 hours
Total Postsurgical Opioid Consumption Through 48 Hours
Total postsurgical opioid consumption (converted to IV morphine equivalents) through 48 hours
Time frame: 0-48 hours
Percentage of Opioid-free Participants Through 48 Hours
Percentage of participants who did not receive opioid medication through 48 hours
Time frame: 0-48 hours
Time to First Opioid Rescue Through 48 Hours
Time to first opioid rescue medication consumed through 48 hours. Time to rescue was estimated from Kaplan-Meier analysis and presented as quartiles (ie, time to rescue for the first 25% / 50% / 75% of subjects within each treatment group).
Time frame: 0-48 hours
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Jackson Memorial Hospital/University of Miami
Miami, Florida, United States
Pensacola Research Associates
Pensacola, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Fairview Hospital
Cleveland, Ohio, United States
Indiana Regional Medical Center
Indiana, Pennsylvania, United States
...and 10 more locations