Analgesic Device for Postoperative Pain After Knee Surgery

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: 2

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to manage pain after certain foot and shoulder surgeries. The device combines a nerve-blocking medicine with gentle electric stimulation (percutaneous peripheral nerve stimulation) to potentially provide up to 28 days of pain relief, which could significantly improve current methods. The trial aims to refine the device's use and assess its effectiveness in real-world settings. Suitable candidates have undergone or will undergo surgeries like rotator cuff repair or ankle surgery and expect significant pain for at least a week post-surgery. Participants will also need a smartphone to use the device's controlling app. As an unphased trial, this study offers patients the chance to contribute to innovative pain management solutions that could enhance recovery experiences for future patients.

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 use opioids or tramadol daily, or if you are on certain blood thinners other than aspirin.

What prior data suggests that this device is safe for postoperative pain management?

Research shows that percutaneous peripheral nerve stimulation (PNS) is generally safe and well-tolerated. Recent studies indicate that this treatment can quickly ease post-surgical pain. For instance, one study found that PNS provided almost immediate relief for patients with knee pain. In another study, 94.4% of patients experienced significant pain relief.

However, not everyone responds the same way. About 10-20% of patients may still feel pain after treatment. Overall, evidence suggests that the treatment is safe for most people, but individual responses can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional pain management options after knee surgery, such as oral medications like opioids and NSAIDs, percutaneous peripheral nerve stimulation offers a unique approach. This method involves a minimally invasive procedure where a small device is placed near nerves to block pain signals. Researchers are excited about this treatment because it directly targets the source of pain and has the potential to reduce reliance on systemic medications, thereby minimizing side effects like nausea and the risk of addiction. Additionally, the use of a device controlled via smartphone app offers patients more personalized and adjustable pain relief.

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

Research has shown that percutaneous peripheral nerve stimulation (PNS) can greatly reduce post-surgical pain. One study found that 94.4% of patients experienced at least a 50% reduction in pain with this method. Other studies have found that PNS improves mobility and reduces long-term pain after knee surgeries. It also provides quick pain relief following surgery. In this trial, participants will receive the RELAY device, which combines a local anesthetic with PNS and may offer longer-lasting pain relief after knee surgery. ^{1 2 4 6 7}

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

I have a smartphone that can download the required app.

I am having surgery on my shoulder, ankle, or foot expected to cause significant pain for a week.

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 knee surgery

7 days

1 visit (in-person) for device insertion

Postoperative Monitoring

Participants are monitored for pain intensity and opioid use during the first week after surgery

1 week

Daily self-reports via phone app

Follow-up

Participants are monitored for safety and effectiveness after device removal

1 week

1 visit (virtual) for follow-up assessment

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?

Group I: Experimental Treatment Experimental Treatment 1 Intervention

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.

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12372923/

60-Day Peripheral Nerve Stimulation in Chronic Knee Pain

Eighteen patients were identified who underwent PNS-therapy, and 94.4% (17/18) of the patients achieved ≥ 50% pain relief (responders) following ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1094715924000643

Randomized Placebo-Controlled Trial of 60-Day ...

This study provides evidence that percutaneous PNS decreases persistent pain, which leads to improved functional outcomes after TKA at EOT.

3.

asra.com

asra.com/docs/default-source/events-education-documents/pm23/abstract-4607.pdf?sfvrsn=6e98e7e7_1

percutaneous pns relieves persistent postoperative ...

Despite positive results for many patients, approximately 10-20% of patients continue to experience persistent postoperative pain following TKA (i.e., pain >3 ...

4.

scholars.duke.edu

scholars.duke.edu/individual/pub1633188

Randomized Placebo-Controlled Trial of 60-Day ...

Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6339601/

A Feasibility Study of Percutaneous Peripheral Nerve ...

Recent studies suggest that percutaneous PNS can produce immediate reductions in postoperative pain following TKA in a brief (single day) in‐office test more ...

6.

orthopedicreviews.openmedicalpublishing.org

orthopedicreviews.openmedicalpublishing.org/article/143096-60-day-peripheral-nerve-stimulation-in-chronic-knee-pain-a-retrospective-analysis

60-Day Peripheral Nerve Stimulation in Chronic Knee Pain

Eighteen patients were identified who underwent PNS-therapy, and 94.4% (17/18) of the patients achieved ≥ 50% pain relief (responders) following ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12273110/

Peripheral Nerve Stimulation for Chronic Knee Pain Following ...

Outcomes reported include improvement in pain scores (8 studies), functional status (6 studies) and medication usage (3 studies). Range of follow-up were 3 days ...