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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07052721
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 5, 2025
Status verified
Jan 2026
Primary completion
May 1, 2026
Completion
May 15, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Neuromodulation
    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.
  • Sham Comparator: Sham Neuromodulation
    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.

Primary Outcome Measure

Average daily pain intensity postoperative days 1-7 [ Time Frame: Days 1-4 and 7 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92137-

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University of California San Diego· La Jolla, CA

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