Analgesic Device for Postoperative Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new device called the RELAY system to manage post-surgical pain. It aims to provide longer-lasting pain relief without opioids or costly procedures. The device combines a one-time nerve block with ongoing pain control for up to 28 days using a small electric current. Individuals undergoing shoulder or foot surgeries who anticipate significant pain may be suitable candidates, particularly if they plan to use a nerve block and have a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management solutions.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using chronic opioids, tramadol, or certain blood thinners other than aspirin.
What prior data suggests that this device is safe for postoperative pain management?
Research has shown that the RELAY system, a new device for managing post-surgical pain, appears promising based on earlier studies. It provides pain relief through one injection and a continuous flow of pain-numbing medicine, followed by gentle electrical pulses. This method could control pain for up to 28 days, much longer than traditional methods.
Regarding safety, the device is designed to be gentle on the body. Studies have not identified any major side effects directly linked to the RELAY system. While more research is needed to fully understand its long-term safety, early results suggest that the device does not cause significant harm when used correctly. Participants in earlier studies used the device without major problems, indicating it may be a safe option for managing pain after surgery.12345Why are researchers excited about this trial?
Unlike the standard treatments for postoperative pain, which often rely on oral medications like opioids or NSAIDs, the RELAY system introduces a novel approach through neuromodulation. This device uses a catheter to deliver localized pain relief directly to the affected area, potentially reducing the need for systemic painkillers and their associated side effects. Researchers are particularly excited about this method because it connects to participants' phones, allowing for personalized and adjustable pain management. Additionally, the option of a sham neuromodulation group highlights the importance of understanding the real effects of the treatment, paving the way for more precise and effective pain relief strategies.
What evidence suggests that the RELAY system is effective for postoperative pain?
Research has shown that the RELAY system, which participants in this trial may receive, could significantly enhance post-surgery pain management. This device provides pain relief through a one-time nerve block injection, a continuous nerve block, and electrical nerve stimulation. Early results suggest that this combination can consistently relieve pain for up to 28 days. Previous studies indicate it may reduce pain more effectively than traditional methods. The system aims to offer long-lasting pain relief without requiring multiple procedures or incurring high costs, making it an exciting option for post-surgery pain management.36789
Who Is on the Research Team?
Brian M Ilfeld, MD, MS
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
This trial is for individuals with shoulder or foot conditions like rotator cuff injuries, bunion correction, and ankle arthritis. Participants should be in need of postoperative pain management after surgery.Inclusion Criteria
Exclusion 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 shoulder or foot surgery
Postoperative Monitoring
Participants are monitored for pain intensity and opioid use, with daily assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RELAY system
Trial Overview
The study tests the RELAY system, a device that delivers local anesthetic and electric current for neuromodulation to control pain after surgery. It offers up to 28 days of analgesia using a single device through various stages.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Diego
Lead Sponsor
Gate Science
Industry Sponsor
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07052721?term=AREA%5BBasicSearch%5D(AREA%5BStudyType%5D(INTERVENTIONAL))&rank=9Randomized Study of an Analgesic Device Enabling Local ...
One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) ...
Analgesic Device for Postoperative Pain · Info for Participants
The RELAY system is unique because it likely involves a novel device-based approach for managing postoperative pain, which may offer more consistent pain relief ...
Percutaneous analgesic device enabling both local ...
This pilot study suggests that a novel percutaneous device successfully integrates both local anesthetic delivery and PNS, and its outpatient ...
Comparing Analgesic Regimen Effectiveness and Safety after ...
The primary effectiveness outcome is patient-reported worst daily pain intensity over the first 7 days after surgery. The primary safety outcome ...
Percutaneous analgesic device enabling both local ...
Participants were contacted by telephone for endpoint collec- tion on postoperative days 0, 1, 2, 3, 7, 8, and 14. We selected outcome measures ...
Percutaneous analgesic device enabling both local ...
This novel device successfully delivered a single-injection local anesthetic bolus, a continuous perineural infusion, ...
Randomized Study of an Analgesic Device ... - Clinical Trial Finder
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 ...
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
The Relay®Pro Thoracic Stent-Graft System (referred to as RelayPro hereafter) is designed to treat fusiform aneurysms and saccular aneurysms/penetrating ...
Postoperative Pain Control - StatPearls - NCBI Bookshelf
Postoperative pain control aims to reduce the negative consequences of acute postsurgical pain and help the patient transition smoothly back to normal function.
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