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NCT06818708 · ClinicalTrials.gov registry record · NA
Feasibility of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery
A NA study of Rotator Cuff Injuries and Hallux Valgus, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06818708 is a NA study of Rotator Cuff Injuries and Hallux Valgus that has completed, run by University of California, San Diego. The registered enrollment target is 20 participants, below the 99-participant average among 10 other Rotator Cuff Injuries trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06818708, a NA study of Rotator Cuff Injuries and Hallux Valgus, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to prepare for a randomized clinical trial investigating the use of the RELAY device to provide postoperative analgesia. This feasibility study will be a series of participants all receiving both local anesthetic and electric current via a single device (RELAY, Gate Science, Moultonborough, New Hampshire). The purpose will be to optimize the insertion approac
Conditions Studied
Interventions
- DEVICE Experimental Treatment
Study Locations (1)
California
- University of California San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-03-20 |
| Est. Completion | 2025-06-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06818708
The ClinicalTrials.gov registry entry for NCT06818708 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 10 other Rotator Cuff Injuries trials with a reported enrollment target (80% lower). The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Rotator Cuff Injuries appearing as the primary indexed condition, and to 1 intervention - of which Experimental Treatment is the first listed.
NCT06818708 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06818708 about?
NCT06818708 is a clinical study titled "Feasibility of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery". Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation o...
What is the current status of trial NCT06818708?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2025-03-20. Estimated completion is 2025-06-26.
What conditions does trial NCT06818708 study?
This clinical trial studies the following conditions: Rotator Cuff Injuries, Hallux Valgus, Shoulder Disease, Ankle Arthropathy.
What interventions are being tested in trial NCT06818708?
The interventions under investigation include: Experimental Treatment (DEVICE).
Who is sponsoring clinical trial NCT06818708?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06818708 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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