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New device could replace opioids for weeks of pain relief after surgery

NCT ID NCT07052721

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tests a device called RELAY that delivers both local anesthetic and mild electrical pulses to nerves after shoulder or foot surgery. The goal is to provide up to 28 days of pain relief, much longer than current options. About 50 adults undergoing specific surgeries will be enrolled. The device is compared to a sham (fake) treatment to see if it reduces pain and the need for opioids.

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

44 people

The number who actually took part.

Started

Sep 2025

Finished

Jun 2026

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, clavicle fracture ORIF, or foot/ankle surgery anticipated to have moderate-to-severe pain for a week after surgery (e.g., ankle arthroplasty/arthrodesis) 3. At least a single-injection peripheral nerve block(s) planned 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 osteoarthritis Rotator Cuff Injuries rotator cuff syndrome Shoulder Injuries

As listed by the trial registrant

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

Ankle arthropathy Clavicle fracture Hallux valgus Rotator cuff tears Shoulder injuries

Contacts and locations

Locations

  • University of California San Diego

    La Jolla, California, 92137, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.