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NCT04571606 · ClinicalTrials.gov registry record · NA
Interscalene Catheter vs. Interscalene Liposomal Bupivacaine for Arthroscopic Rotator Cuff Repair
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT04571606 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 80 participants.
The verdict
NCT04571606, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study 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.
Interventions
- 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2021-07-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04571606
The ClinicalTrials.gov registry entry for NCT04571606 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Single injection peripheral nerve block with liposomal bupivacaine (Exparel) is the first listed.
NCT04571606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04571606 about?
NCT04571606 is a clinical study titled "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 F...
What is the current status of trial NCT04571606?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2020-10-14. Estimated completion is 2021-07-02.
What interventions are being tested in trial NCT04571606?
The interventions under investigation include: 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 (PROCEDURE).
Who is sponsoring clinical trial NCT04571606?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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