Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single injection peripheral nerve block with liposomal bupivacaine (Exparel)
Single injection peripheral nerve block with 0.25% bupivacaine and subsequent peripheral nerve catheter with 0.2% bupivacaine infusion via onQ pain pump
Sponsored by

About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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.
Sites / Locations
- University of North Carolina Ambulatory Surgery Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Liposomal Bupivacaine
Peripheral Nerve Catheter
Arm Description
Pre-operative ultrasound guided interscalene nerve block with 10 mL 1.3% liposomal bupivacaine (Exparel) and 10 mL 0.5% bupivacaine
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04571606
First Posted
September 25, 2020
Last Updated
July 12, 2021
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04571606
Brief Title
Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair
Official Title
Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine
Arm Type
Active Comparator
Arm Description
Pre-operative ultrasound guided interscalene nerve block with 10 mL 1.3% liposomal bupivacaine (Exparel) and 10 mL 0.5% bupivacaine
Arm Title
Peripheral Nerve Catheter
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Single injection peripheral nerve block with liposomal bupivacaine (Exparel)
Intervention Description
10 mL/133 mg liposomal bupivacaine and 10 mL 0.5% bupivacaine
Intervention Type
Procedure
Intervention Name(s)
Single injection peripheral nerve block with 0.25% bupivacaine and subsequent peripheral nerve catheter with 0.2% bupivacaine infusion via onQ pain pump
Intervention Description
20 mL 0.25% bupivacaine block and subsequent 10 mL/hr 0.2% bupivacaine infusion for 48 hours
Primary Outcome Measure Information:
Title
Quality of Recovery 15 Score (QOR15)
Description
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.
Time Frame
48 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Opioid Dose in Morphine Equivalents
Description
total opioid administered over the first 3 postoperative days
Time Frame
postoperative days 1, 2 & 3
Title
Percentage of Patients with a Highest Pain Score > 3
Description
Visual analog pain scores after operation [0-10, with 10 being the worst pain]
Time Frame
postoperative days 1, 2 & 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Schoenherr, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina Ambulatory Surgery Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair
We'll reach out to this number within 24 hrs