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
Trial Information
Current as of July 24, 2025
Not yet recruiting
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)
About University Of California, San Diego
The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
La Jolla, California, United States
Patients applied
Trial Officials
Brian M Ilfeld, MD, MS
Principal Investigator
University of California, San Diego
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported