- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571606
Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair
July 12, 2021 updated by: University of North Carolina, Chapel Hill
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27516
- University of North Carolina Ambulatory Surgery Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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.
|
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)
Time Frame: 48 hours postoperatively
|
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
Time Frame: postoperative days 1, 2 & 3
|
total opioid administered over the first 3 postoperative days
|
postoperative days 1, 2 & 3
|
Percentage of Patients with a Highest Pain Score > 3
Time Frame: postoperative days 1, 2 & 3
|
Visual analog pain scores after operation [0-10, with 10 being the worst pain]
|
postoperative days 1, 2 & 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jay Schoenherr, MD, University of North Carolina, Chapel Hill
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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