Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
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)
Johnny K. Lee
120 participants
Sep 8, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Subject ages 18-90 years old
- Male or Female subjects
- Weight ≥ 60 kg.
- Must be able to consent in English
Exclusion Criteria11
- Ages: \<18 and \>90
- Weight \< 60 kg
- Multiple surgeries during one hospital stay
- Emergency surgery
- Allergy or any contraindication to local anesthetics used in trial.
- Pregnancy
- Contraindicated for use of liposomal bupivacaine
- Severe liver/kidney disease
- Defined as a diagnosis of end-stage renal disease (ESRD) defined as being on dialysis
- Subject who received another local anesthetic block prior to the interscalene block.
- Unable to consent in English
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Interventions
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).
Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05900427