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Single device could replace opioids for weeks after surgery

NCT ID NCT06818708

Symptom relief Sponsor: University of California, San Diego Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device called RELAY that delivers both local anesthetic and mild electrical stimulation through a single catheter to control pain after shoulder or foot surgery. Twenty adults who had surgery for rotator cuff tears, shoulder replacement, or foot problems took part. The goal was to see if the device could provide up to 28 days of pain relief, compared to the usual 24-72 hours from standard nerve blocks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RELAY device (catheter with local anesthetic and electrical nerve stimulation)
What this could lead to
If it works, this device could provide up to 28 days of pain relief after surgery using a single placement, reducing the need for opioids.
What could go wrong
This is a small, early feasibility study with only 20 participants. The device is still experimental, and results may not apply to everyone. Risks include infection or nerve damage from the device.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Mar 2025

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult participants of at least 18 years of age 2. Undergoing a rotator cuff repair, total shoulder arthroplasty, ankle arthroplasty/arthrodesis, or foot surgery anticipated to result in moderate-to-severe pain for at least one week 3. Planned single-injection peripheral nerve block(s) 4. An Android or Apple smartphone able to download the Gate Keeper controller app Exclusion Criteria: 1. Chronic opioid or tramadol use (daily within prior 2 weeks and duration \> 4 weeks) 2. Neuro-muscular deficit of the surgical limb 3. Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk of infection 4. Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap 5. History of bleeding disorder 6. Antiplatelet or anticoagulation therapies other than aspirin 7. Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.) 8. Incarceration 9. Pregnancy 10. Moderate pain (NRS \> 3) in an anatomic location other than the surgical site 11. Anxiety disorder 12. History of substance misuse 13. Inability to communicate with the investigators 14. Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access) 15. Allergy to amide local anesthetics 16. Morbid obesity (body mass index \> 40 kg/m2)

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Conditions

The condition(s) this trial relates to.

arthropathy Hallux Valgus Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankle arthropathy Hallux valgus Rotator cuff injuries Shoulder disease

Contacts and locations

Locations

  • University of California San Diego

    La Jolla, California, 92037, United States

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