Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair

University of North Carolina (UNC)

Status: Completed

Conditions: Pain, Postoperative

Treatments: Procedure: Single injection peripheral nerve block with liposomal bupivacaine (Exparel); Procedure: Single injection peripheral nerve block with 0.25% bupivacaine and subsequent peripheral nerve catheter with 0.2% bupivacaine infusion via onQ pain pump

Study type: Interventional

Funder types: Other

Identifiers

NCT04571606

19-3303

Details and patient eligibility

About

Arthroscopic rotator cuff repair often causes significant postoperative pain. An interscalene nerve catheter is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of shoulder surgery. Liposomal bupivacaine (Exparel) was recently approved by the FDA for use around the interscalene brachial plexus, and it has been shown to be an effective option, but its analgesic efficacy has limited data. Both techniques are currently being used at the UNC's Ambulatory Surgery Center (ASC) for analgesia after shoulder arthroscopy. The goal is to ensure that the fairly new Exparel option provides non-inferior analgesia as compared to the prior standard practice of placing a nerve catheter with plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of shoulder arthroscopy at this institution by prospectively and rigorously collecting data during regular follow up.

Full description

This is a prospective comparison of patients undergoing rotator cuff repair that receive one of two types of interscalene nerve block, both of which are currently being used at UNC. Group 1 will be comprised of patients with a preoperative interscalene nerve catheter placed with 20 mL 0.25% bupivacaine and a 0.2% ropivacaine infusion by an OnQ pain pump. Group 2 will be comprised of patients with a preoperative interscalene nerve block placed with 10 mL 0.5% bupivacaine and 10 mL 1.3% Liposomal Bupivacaine (Exparel). All patients in both groups will have a similar intraoperative general anesthetic with multimodal analgesic pre-op oral medications.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Adult patients age > 18 undergoing arthroscopic rotator cuff repair at the ambulatory surgery center at the University of North Carolina

Exclusion Criteria: the below are simply contraindications to regional anesthesia in general, this is a pragmatic study to evaluate the quality of care for these patients with no additional exclusion criteria.

• Contraindications to regional anesthesia
• Significant peripheral neuropathy or neurological disorder affecting the upper extremity
• Pregnancy
• Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Liposomal Bupivacaine

Active Comparator group

Description:

Pre-operative ultrasound guided interscalene nerve block with 10 mL 1.3% liposomal bupivacaine (Exparel) and 10 mL 0.5% bupivacaine

Treatment:

Procedure: Single injection peripheral nerve block with liposomal bupivacaine (Exparel)

Peripheral Nerve Catheter

Active Comparator group

Description:

Pre-operative ultrasound guided interscalene nerve block with 20 mL of 0.25% bupivacaine and placement of peripheral nerve catheter with 10 mL/hr 0.2% bupivacaine infusion via OnQ pump.

Treatment:

Procedure: Single injection peripheral nerve block with 0.25% bupivacaine and subsequent peripheral nerve catheter with 0.2% bupivacaine infusion via onQ pain pump