N/A
N=20
Feasibility of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery
Rotator Cuff Injuries · Shoulder Disease · Hallux Valgus · Ankle Arthropathy
Bottom Line
View on ClinicalTrials.gov: NCT06818708 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Average Daily Pain Intensity 1st Week — 2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Diego
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Daily Pain Intensity 1st Week |
2 | — |
| SECONDARY Cumulative Opioid Use 1st Week |
43 | — |
| SECONDARY Brief Pain Inventory (Interference Sub Scale) Day 3 |
2 | — |
| SECONDARY Brief Pain Inventory (Interference Sub Scale) Day 7 |
— | — |
| SECONDARY Worst Daily Pain Intensity 1st Week |
4.0 | — |
| SECONDARY Awakenings Due to Pain 1st Week |
2 | — |
| SECONDARY Average Daily Pain Intensity Day 7 |
— | — |
| SECONDARY Worst (Maximum) Daily Pain Intensity Day 7 |
1.8 | — |
| SECONDARY Opioid Consumption Day 7 |
— | — |
| SECONDARY Daily "Average" Pain Intensity |
3; 2; 2; 1; 0; 0 | — |
| SECONDARY Daily "Worst" Pain Intensity |
5; 4.5; 4.3; 3; 1.8; 2 | — |
| SECONDARY Daily Opioid Consumption |
0.3; 0; 0; 0; 0; 0 | — |
Summary
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 prepare for a randomized clinical trial investigating the use of the RELAY device to provide postoperative analgesia.
This feasibility study will be a series of participants all receiving both local anesthetic and electric current via a single device (RELAY, Gate Science, Moultonborough, New Hampshire). The purpose will be to optimize the insertion approach and stimulation administration during the first 7 days following foot and shoulder surgery as well as training the clinical investigators.
Eligibility Criteria
Inclusion Criteria
- Adult participants of at least 18 years of age
- 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
- Planned single-injection peripheral nerve block(s)
- An Android or Apple smartphone able to download the Gate Keeper controller app
Exclusion Criteria
- Chronic opioid or tramadol use (daily within prior 2 weeks and duration > 4 weeks)
- Neuro-muscular deficit of the surgical limb
- 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
- Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
- History of bleeding disorder
- Antiplatelet or anticoagulation therapies other than aspirin
- Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
- Incarceration
- Pregnancy
- Moderate pain (NRS > 3) in an anatomic location other than the surgical site
- Anxiety disorder
- History of substance misuse
- Inability to communicate with the investigators
- Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
- Allergy to amide local anesthetics
- Morbid obesity (body mass index > 40 kg/m2)
Data sourced from ClinicalTrials.gov (NCT06818708). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.