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

Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Feb 7, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new device called the RELAY system, which aims to help manage pain after shoulder or foot surgery. After these surgeries, pain can be strong and last for several days, but current pain relief options either don’t last long enough or can have side effects. The RELAY device is designed to deliver local anesthesia (numbing medicine) directly to the nerves near the surgery site and then provide gentle electrical stimulation for up to 28 days through the same device. This combination could offer longer-lasting pain relief without needing multiple procedures or high doses of opioids (strong pain medicines that have risks).

Adults 18 years and older who are having certain types of shoulder or foot surgeries and expect moderate to severe pain may be eligible to join. Participants need to be planning to receive a single nerve block injection for pain and have a smartphone to use a related app. During the study, participants will receive the RELAY device after their surgery and will be monitored for up to a week to see how well the device works and how to best place it. The goal is to improve pain control after surgery with a simpler, longer-lasting option. People with certain medical conditions or who use opioids regularly may not qualify, so doctors will review each person’s health before joining.

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, 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)