Liposomal Bupivacaine in Rotator Cuff Repair

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Rotator Cuff Injury

Treatments: Drug: Exparel; Drug: Ropivacaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03738696

IRB-300002544

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Liposomal bupivacaine Interscalene Block

Experimental group

Description:

Interscalene block: * 10cc (133mg) liposomal bupivacaine;PLUS * 10cc 0.25% bupivacaine

Treatment:

Drug: Exparel

Ropivacaine Interscalene Catheter

Active Comparator group

Description:

* 20cc 0.25% bupivacaine interscalene block; PLUS * Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)

Treatment:

Drug: Ropivacaine