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

NCT04571606 | Completed

• 1 other identifier: 19-3303
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery 15 Score (QOR15)

  The QoR15 provides a valid, extensive, and efficient evaluation of postoperative quality of recovery. The QOR15 has 15 questions on a 0-10 point scale, so the QOR15 score can range from 0-150, the higher the score, the better the quality of recovery.

  48 hours postoperatively

Other Outcomes (2)

• Opioid Dose in Morphine Equivalents

  postoperative days 1, 2 & 3

• Percentage of Patients with a Highest Pain Score > 3

  postoperative days 1, 2 & 3

Study Arms (2)

Liposomal Bupivacaine

ACTIVE COMPARATOR

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

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

Peripheral Nerve Catheter

ACTIVE COMPARATOR

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.

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

Interventions

Single injection peripheral nerve block with liposomal bupivacaine (Exparel) PROCEDURE

10 mL/133 mg liposomal bupivacaine and 10 mL 0.5% bupivacaine

Liposomal Bupivacaine

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

20 mL 0.25% bupivacaine block and subsequent 10 mL/hr 0.2% bupivacaine infusion for 48 hours

Peripheral Nerve Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina Ambulatory Surgery Center

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jay Schoenherr, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 1, 2020
• Study Start: October 14, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 2, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months following publication
• Access Criteria: Approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC

Locations

US (1)