NCT03913091

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Shoulder Pain

Interventions

Type	Name	Description
DRUG	Liposomal Bupivacaine	Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
DRUG	0.5% Bupivacaine HCL	0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)

Timeline

• Start date: 2019-03-01
• Primary completion: 2021-01-19
• Completion: 2021-01-19
• First posted: 2019-04-12
• Last updated: 2022-02-01
• Results posted: 2022-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study