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Clinical trial

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)

ID
Name
EH23-069
Description
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).
Trial arms
Trial start
2023-09-08
Estimated PCD
2024-09-01
Trial end
2024-10-01
Status
Recruiting
Phase
Early phase I
Treatment
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).
Arms:
Liposomal Bupivacaine Group
Other names:
Exparel
Bupivacaine
Subjects randomized to the Plain Bupivacaine group will receive 36 mL (180 mg) of 0.5% bupivacaine.
Arms:
Plain Bupivacaine Group
Other names:
Marcaine
Size
120
Primary endpoint
The difference in the proportion of patients with clinically significant tolerable pain scores
at Post-operative Day 1
Eligibility criteria
Inclusion Criteria: * Subject ages 18-90 years old * Male or Female subjects * Weight ≥ 60 kg. * Must be able to consent in English Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-09-13

1 organization

2 products

2 indications

Organization
Johnny K. Lee
Product
Liposomal bupivacaine
Indication
Shoulder Arthroplasty
Indication
Reverse Total Shoulder Arthroplasty
Product
Bupivacaine