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

• Status: Suspended
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrews Research & Education Foundation
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine; Narcotics

Criteria

Inclusion Criteria:

• Male or female

• 18-72 years of age

• Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators

Exclusion Criteria:

• Planned concomitant glenoid labral repair

• Previous open shoulder surgery

• Neurological deficit or other disability involving the surgical extremity

• Anyone with a documented allergy to bupivicaine

• Subjects that are not mentally competent to give consent

• Pregnant women

• Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication