NCT03290196

The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Andrews Research & Education Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 72 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.

Detailed description

Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
DRUG	EXPAREL 1.3 % in 20 ML Injection	EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.

Timeline

• Start date: 2015-09-03
• Primary completion: 2016-12-22
• Completion: 2022-04-07
• First posted: 2017-09-21
• Last updated: 2025-03-30
• Results posted: 2025-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study