Analgesic Device for Postoperative Pain After Knee Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are having certain shoulder or foot surgeries expected to cause moderate-to-severe pain for at least a week. They must plan to have a single-injection nerve block and own an Android or Apple smartphone that can download the required app.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the RELAY device for local anesthetic delivery and neuromodulation following knee surgery
Postoperative Monitoring
Participants are monitored for pain intensity and opioid use during the first week after surgery
Follow-up
Participants are monitored for safety and effectiveness after device removal
What Are the Treatments Tested in This Trial?
Interventions
- Percutaneous peripheral nerve stimulation
Trial Overview
The RELAY system, which combines local anesthetic delivery with electric current neuromodulation through one device, is being tested. It aims to provide up to 28 days of postoperative pain control after knee surgery, improving on current methods limited to hours or days.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Gate Science
Industry Sponsor
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