Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)

• Status: Completed
• Trial end date: 2021-01-19
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Patients undergoing total shoulder arthroplasty;

• Patients who consent to be randomized.

Exclusion Criteria:

• Patients younger than 18 and older than 75;

• Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;

• Patients who are allergic to oxycodone;

• Patients who are unable to speak English;

• Patients with diagnosed or self---reported cognitive dysfunction;

• Patients with a history of neurologic disorder that can interfere with pain sensation;

• Patients with a history of drug or recorded alcohol abuse;

• Patients who are unable to understand or follow instructions;

• Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;

• Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;

• Patients with BMI over 40;

• Any patient that the investigators feel cannot comply with all study related procedures;

• NYU Langone Health students, residents, faculty or staff members