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)

NYU Langone Health

Status and phase

Completed

Phase 4

Conditions

Shoulder Pain

Treatments

Drug: 0.5% Bupivacaine HCL

Drug: Liposomal Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03913091

18-01183

Details and patient eligibility

About

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.

Enrollment

184 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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