CompletedPhase 4

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)

United States184 participantsStarted 2019-03-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Opioid Utilization

Timeframe: 24-72 hour, Post-Operative Period

Trial details

NCT IDNCT03913091

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-19

Results submitted2022-01-03