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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571606
• Other study ID #: 19-3303
• Status: Completed
• Phase: N/A
• Start date: October 14, 2020
• Est. completion date: July 2, 2021

Study information

• Verified date: February 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Single injection peripheral nerve block with liposomal bupivacaine (Exparel)
10 mL/133 mg liposomal bupivacaine and 10 mL 0.5% bupivacaine
• 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

Locations

Country	Name	City	State
United States	University of North Carolina Ambulatory Surgery Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Opioid Dose in Morphine Equivalents	total opioid administered over the first 3 postoperative days	postoperative days 1, 2 & 3
Other	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
Primary	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