A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty

IRB-19-7479

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

2021-03-01

2025-03-01

2025-07-01

Recruiting

Early phase I

150

Inclusion Criteria: • Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty Exclusion Criteria: * Patients under the age of 50 years * Patients over the age of 85 * Patients undergoing a revision shoulder procedure * Documented drug or alcohol abuse * Active narcotic use within 3 months prior to surgery * Neurological deficit * Allergy to amide anesthetics * Oxycodone intolerance * Unable to take Celebrex * Enrollment in another clinical trial * Comorbidity that is contraindicated with the administration of an interscalene block * Cognitive or mental health status that interferes with study

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double Blinded Randomized Controlled Trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Patients will be blinded. Surgeon, nurses, and other clinical care providers will be blinded. Research staff will be blinded. The only staff who knows study group assignment is the pharmacist and the anesthesiologist and preoperative nurse who will administer the interscalene block.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-01-03