Analgesic Device for Postoperative Pain

Overseen By Baharin Abdullah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Opioids, Tramadol, Anticoagulants

Disqualifiers: Neuro-muscular deficit, Immunocompromised, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device for managing pain after surgery, focusing on foot and shoulder operations. The device, called RELAY, combines pain relief methods by using a local anesthetic and electric current. It may provide pain relief for up to 28 days, significantly longer than current methods. Suitable candidates for this trial include those undergoing rotator cuff, shoulder, ankle, or foot surgery who expect significant pain for at least a week post-surgery. Participants must use a smartphone to manage the device settings. As an unphased trial, this study offers patients the chance to participate in innovative research that could greatly improve post-surgical pain management.

Will I have to stop taking my current medications?

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 device for managing post-surgical pain, is under study for its potential to provide long-lasting relief. Past studies of similar devices have generally found them to be well-tolerated, with a focus on understanding any side effects. While detailed safety information specific to the RELAY system is limited, the device is designed to deliver both local anesthetics and electric currents. This combination aims to reduce pain for up to 28 days without requiring additional procedures.

Devices like this are usually closely monitored for any negative effects. Patients might experience common side effects seen with other pain management systems, such as temporary numbness or tingling. However, studies so far have not identified any major safety concerns. Since this trial is in the early testing stages, understanding the safety of the RELAY system in humans remains a key focus. Participants can expect close monitoring to ensure any side effects are promptly addressed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The RELAY system is unique because it combines a catheter with ultrasound guidance to deliver local anesthetics directly to the site of pain, which is different from traditional oral or intravenous pain medications. This method allows for targeted pain relief, potentially reducing the need for systemic opioids and their associated side effects. Researchers are excited about this treatment because it also integrates smartphone connectivity to control the pain management process, offering a personalized and potentially more effective approach to postoperative pain relief.

What evidence suggests that the RELAY system is effective for postoperative pain?

Research has shown that the RELAY system, which trial participants will receive, could transform post-surgery pain management. This device can provide pain relief for up to 28 days, far exceeding the typical 1 to 3 days with current methods. Studies have found that this system offers consistent pain relief without disrupting other medical treatments. The RELAY system uses a local painkiller combined with a mild electrical current to manage pain effectively. Early results suggest that this method might reduce the need for opioids, which have many known issues. This could significantly improve recovery for surgical patients. ^{1 4 6 7 8}

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?

Adults at least 18 years old who are having surgery for rotator cuff repair, total shoulder arthroplasty, hallux valgus correction or ankle arthroplasty/arthrodesis. They must plan to have a single-injection peripheral nerve block and own an Android or Apple smartphone to download a required app.

Inclusion Criteria

I have a smartphone that can download the required app.

I am having surgery for my shoulder, big toe, or ankle.

I am scheduled for a one-time nerve block injection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive the RELAY device for local anesthetic delivery and neuromodulation following shoulder or foot surgery

7 days

1 visit (in-person) for device insertion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain intensity and opioid consumption

14 days

2 visits (virtual) for follow-up assessments

Device Removal

Participants or their caretakers remove the RELAY device at home after 7 days

1 day

What Are the Treatments Tested in This Trial?

Interventions

• RELAY system

Trial Overview The RELAY system is being tested for its ability to deliver both local anesthesia and electric current via one device after foot or shoulder surgery. This study aims to optimize the use of this device over the first week post-surgery and train clinical investigators.

How Is the Trial Designed?

Group I: Experimental Treatment Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Gate Science

Industry Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Epidural analgesia is more effective than systemic analgesia in managing postoperative pain, leading to benefits like earlier ambulation and hospital discharge.

Spinal opioids and various neural blockade techniques, such as intercostal nerve block, can significantly reduce postoperative pain and narcotic use, improving recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of postoperative pain: review of current techniques and methods. Lutz, LJ., Lamer, TJ.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07052721

Randomized Study of an Analgesic Device Enabling Local ... 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 ...

2. rapm.bmj.com rapm.bmj.com/content/early/2025/09/25/rapm-2025-107029

Percutaneous analgesic device enabling both local ... Introduction. Postoperative pain is often undertreated due to lack of effective analgesics. Opioids have significant well-known limitations, ...

3. withpower.com withpower.com/trial/phase-hallux-valgus-2-2025-1c1a3

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 ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK544298/

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.

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06463899

Study Details | NCT06463899 | Evaluation of the ... Limiting postoperative pain allows better rehabilitation of the patient by improving patient mobilization, participation in respiratory physiotherapy and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41005804/

Percutaneous analgesic device enabling both local ... An integrated electrode and pulse generator enable PNS for up to 28 days. Such an approach may represent a paradigm shift in postoperative pain ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/P200045B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The warnings and precautions can be found in the Relay®Pro Thoracic Stent-Graft System labeling. V. DEVICE DESCRIPTION. The Relay®Pro Thoracic Stent-Graft ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S152490422200220X

The First Comprehensive Survey of the Practice ... The questionnaire covered three topics: (1) institution related data; (2) postoperative pain assessment, treatment, and documentation related data; and (3) ...