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NCT05521516 · ClinicalTrials.gov registry record · NA
Percutaneous Auricular Neuromodulation for Postoperative Analgesia
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 122
- Enrollment target
NCT05521516 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 122 participants.
The verdict
NCT05521516, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
Study Summary
The moderate-to-severe pain many patients experience following surgery is often treated with opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory depression (and a risk of abuse, dependence, and diversion). Potent site-specific analgesia with fewer side effects may be provided with peripheral nerve blocks. However, these too have limitations such as a duration of action measured in hours, while the pain from surgery is usually measured in days or weeks. Peripheral nerve stimulation or "neuromodulation" is an alternative method of pain control involving the introduction of electrical current to stimulate various nerves that do not carry pain sensations, but which then decreases communication between pain fibers and the spinal cord and/or brain. Placing small electrodes specifically in the area of the ear is called "auricular neuromodulation" and is theorized to function by stimulating various cranial and peripheral nerves that influence a part of the brain called the "limbic system" which is involved with many aspects of behavior including responses to stress. A device that delivers auricular neuromodulation, the "Bridge" system, is approved by the United States Food and Drug Administration for use to reduce symptoms associated with opioid withdrawal for up to 5 days. However, one prospective and two published retrospective studies suggest that it may provide postoperative analgesia as well. The device itself is relatively simple to apply; has few contraindications, side effects, or adverse events; and has no potential for dependence, abuse, or diversion. Therefore, it has the potential to concurrently improve analgesia and decrease or even negate opioid requirements following surgery, only without the limitations of opioids and peripheral nerve blocks. The purpose of this pilot study is to explore the possibility of treating postoperative pain with percutaneous auricular neuromodulation, optimize the study protocol, and
Interventions
- DEVICE Sham Treatment
- DEVICE Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2024-12-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05521516
The ClinicalTrials.gov registry entry for NCT05521516 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham Treatment is the first listed.
NCT05521516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05521516 about?
NCT05521516 is a clinical study titled "Percutaneous Auricular Neuromodulation for Postoperative Analgesia". The moderate-to-severe pain many patients experience following surgery is often treated with opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory depression (and a risk of abuse, dependence, and diversion). Potent site-specific analgesia with fewer side ...
What is the current status of trial NCT05521516?
This trial is currently completed. It is a NA study. The enrollment target is 122 participants. The study started on 2022-10-12. Estimated completion is 2024-12-11.
What interventions are being tested in trial NCT05521516?
The interventions under investigation include: Sham Treatment (DEVICE), Active Percutaneous Auricular Neuromodulation with NSS-2 Bridge (DEVICE).
Who is sponsoring clinical trial NCT05521516?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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