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

NCT07052721 | Enrolling By Invitation FDA Device

• 1 other identifier: RELAY Randomized
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 investigate the post-operative analgesic potential of this investigational device and prepare for a pivotal multicenter clinical trial.

Conditions

Shoulder Injuries; Hallux Valgus; Ankle Arthropathy; Clavicle Fracture; Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

• Average daily pain intensity postoperative days 1-7

  The median of 4 daily "average" pain intensity scores for Days 1-4 and 7 as measured with the Numeric Rating Scale (0 minimum=best; 10 maximum=worst) collected on Days 2, 3, 4, and 7 for the previous 24 hours each.

  Days 1-4 and 7

Secondary Outcomes (12)

• Cumulative opioid use 1st week

  The first 7 days following surgery

• Brief Pain Inventory (interference sub scale)

  Postoperative days 3 and 7

• Worst/maximum daily pain intensity postoperative days 2-7

  Days 1-4 and 7

• Awakenings due to pain 1st week, cumulative

  Collected on postoperative days 1-7

• Nightly awakenings due to pain

  Collected on postoperative days 1-4, 7, 8, and 14

Study Arms (2)

Active Neuromodulation

EXPERIMENTAL

RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7.

Device: Experimental Treatment

Sham Neuromodulation

SHAM COMPARATOR

RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on, but no current will reach the electrodes or patient's body. The catheters will be removed on postoperative day 7.

Device: Sham Comparator

Interventions

Experimental Treatment DEVICE

Percutaneous peripheral nerve stimulation with a frequency of 100 Hz, a pulse duration of 100 µs, and a current amplitude of 0.001-10 mA (1-10,000 µA). Participants will adjust the amplitude, as needed.

Also known as: percutaneous peripheral nerve stimulation

Active Neuromodulation

Sham Comparator DEVICE

SHAM percutaneous peripheral nerve stimulation with a frequency of 100 Hz, a pulse duration of 100 µs, and a current amplitude of 0.001-10 mA (1-10,000 µA). Participants can adjust the amplitude, as needed; but no electrical current will ever reach the patient's body.

Also known as: Placebo

Sham Neuromodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants of at least 18 years of age
• 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)
• At least a single-injection peripheral nerve block(s) planned
• An Android or Apple smartphone able to download the Gate Keeper controller app

You may not qualify if:

• 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

Sponsors & Collaborators

• Gate Science: collaborator
• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92137, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Injuries; Hallux Valgus

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Tendon Injuries; Foot Deformities; Musculoskeletal Diseases

Study Officials

• Brian M Ilfeld, MD, MS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Pulse generators are available that are capable of either (1) passing electrical current; or (2) not passing electrical current. Importantly, these 2 modes (active and sham) are indistinguishable in appearance, and therefore investigators, participants, and all clinical staff will be masked to treatment group assignment, with the only exception being the unmasked individuals who insert the RELAY and program the stimulator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Model Details: Single center, randomized, observer- and participant-masked, sham-controlled parallel group study

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 6, 2025
• Study Start: September 5, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (1)