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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: 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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • University of North Carolina Ambulatory Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Liposomal Bupivacaine; 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); 10 mL/133 mg liposomal bupivacaine and 10 mL 0.5% bupivacaine
Active Comparator: Peripheral Nerve Catheter; 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; 20 mL 0.25% bupivacaine block and subsequent 10 mL/hr 0.2% bupivacaine infusion for 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Dose in Morphine Equivalents	total opioid administered over the first 3 postoperative days	postoperative days 1, 2 & 3
Percentage of Patients with a Highest Pain Score > 3	Visual analog pain scores after operation [0-10, with 10 being the worst pain]	postoperative days 1, 2 & 3

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Jay Schoenherr, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 2, 2021

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 19-3303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No