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)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• Subject ages 18-90 years old

• Male or Female subjects

• Weight ≥ 60 kg.

• Must be able to consent in English

Locations
United States
Illinois
NorthShore University HealthSystem
RECRUITING
Skokie
Contact Information
Primary
Johnny K Lee, MD
anesthesiaresearch@northshore.org
847-570-2760
Time Frame
Start Date: 2023-09-08
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 120
Treatments
Experimental: Liposomal Bupivacaine Group
10 mL (133 mg) Liposomal bupivacaine and 20 mL (50 mg) 0.25% bupivacaine and 6 mL of saline (183 mg)
Other: Plain Bupivacaine Group
36 mL (180 mg) 0.5% bupivacaine
Related Therapeutic Areas
Sponsors
Collaborators: Endeavor Health
Leads: Johnny K. Lee

This content was sourced from clinicaltrials.gov

Similar Clinical Trials