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Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
Sponsor: Johnny K. Lee
Summary
The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours postoperatively) in patients undergoing shoulder arthroplasty who receive interscalene blocks with or without Liposomal Bupivacaine. This is a prospective randomized, double-blinded, controlled trial that will enroll 130 subjects undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty. Participants who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either 36 mL of 0.5% bupivacaine (PB group) or 10 mL of liposomal bupivacaine and 20 mL of 0.25 % bupivacaine and 6 mL of saline (LB group).
Official title: A Double-Blind Randomized Comparison Trial of Postoperative Pain in Patients Undergoing Total Shoulder Arthroplasty Who Receive Interscalene Blocks With or Without Liposomal Bupivacaine (PoPTSAWoW Trial)
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-09-08
Completion Date
2026-03-01
Last Updated
2025-08-14
Healthy Volunteers
Yes
Interventions
Liposomal bupivacaine
Subjects randomized to the Liposomal bupivacaine group will receive 10 mL (133 mg) of Liposomal bupivacaine and 20 mL (50 mg) of 0.25% bupivacaine and 6 mL of saline (183 mg).
Bupivacaine
Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.
Locations (1)
NorthShore University HealthSystem
Skokie, Illinois, United States