Liposomal Bupivacaine in Rotator Cuff Repair

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

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

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine; Ropivacaine; Sodium Channel Blockers

Criteria

Inclusion Criteria:

• Undergoing outpatient arthroscopic rotator cuff repair

• Greater than or equal to 19 years of age at the time of surgery

Exclusion Criteria:

• Planned operative fixation of the biceps tendon or acromioclavicular joint

• Opioid use 6 weeks before surgery

• Gabapentin use 6 weeks before surgery

• History of prior shoulder surgery on the operative limb

• Severe pulmonary dysfunction

• Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)

• History of radicular pain or neuropathy in the operative limb

• Patients who are currently incapacitated for medical decision making