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Sponsor: University of California, San Diego
Conditions: Rotator Cuff Tears, Shoulder Injuries, Hallux Valgus, Ankle Arthropathy, Clavicle Fracture
Interventions: Experimental Treatment, Sham Comparator
Countries: United States
Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to investigate the post-operative analgesic potential of this investigational device and prepare for a pivotal multicenter clinical trial.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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)
- La Jolla, California, United States