Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

NCT ID: NCT02762071


Title
Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
Purpose
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.
Details
After the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial. Consent will be completed after explanation of each treatment group and the data to be collected. Patient age, gender, BMI, and American Society of Anesthesiologists (ASA) score will be recorded as baseline demographic data. Patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: Group 1 will receive interscalene nerve block, Group 2 will receive liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site. The surgeon will perform randomization when the patient enters the preoperative area. The surgeon at each site will be trained prior to enrollment on the correct way to perform Exparel injections intraoperatively. Patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist. Surgical time, type of implant, incision length, and amount of anesthesia required will be recorded for each patient. Patients will record their pain scores, medication and side effects data after surgery until 96 hours after surgery. Our primary analysis data points for pain scores and pain medication use will be 24 hours, 48 hours, 72 hours, 96 hours, and 2 weeks after surgery. The outcome assessor on the study team will be blinded to the treatment group.
Conditions
Osteoarthritis, Arthropathy, Shoulder Pain, Closed Fracture Proximal Humerus, Four Part
Keywords
Source
Johns Hopkins University
Sponsors
Johns Hopkins University, University of Texas Southwestern Medical Center, Southern Maryland Orthopaedic & Sports Medicine Center, William Beaumont Army Medical Center
Status
Recruiting
Acronym
Last Updated
01 May 2016
URL
Official Link
Locations
United States