NCT06575010

Exparel v Dexamethasone in RCR

Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.

Conditions

• Rotator Cuff Tears
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery
DRUG	Bupivacaine Hcl 0.5% Inj	0.75% bupivacaine will be given in the shoulder block prior to surgery
DRUG	Dexamethasone	10 mg Dexamethasone will be given in the shoulder block prior to surgery

Timeline

• Start date: 2024-08-26
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study