Randomized Study of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Jun 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the RELAY system, designed to help manage pain after shoulder or foot surgery. After surgery, pain can be tough to control, and current options like opioids have side effects, while nerve blocks (which numb the area) usually last only a few days. The RELAY device aims to provide longer-lasting pain relief—up to 28 days—by delivering a local anesthetic (a medicine that numbs the area) and gentle electrical stimulation through a small catheter placed near the nerves. This could mean better pain control without needing extra procedures or strong pain medicines.

Adults aged 18 and older who are having certain types of shoulder or foot surgeries that cause moderate to severe pain and who are planning to receive a nerve block might be eligible. Participants will use a smartphone app to help manage the device. During the first week after surgery, the medical team will work with participants to find the best way to use the device and adjust the electrical stimulation for pain relief. The study is still in early stages and not yet recruiting, but it aims to improve how pain is treated after surgery in a safe and convenient way.

Gender

ALL

Eligibility criteria

• 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)