100 Participants NeededMy employer runs this trial

Suzetrigine for Postoperative Pain

RA
Overseen ByRodney A Gabriel
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Diego
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of suzetrigine in easing post-surgery pain, particularly for individuals who might require long-term opioid use. Suzetrigine is a non-opioid pain medication that blocks pain signals without the addiction risks associated with opioids. The trial will compare standard pain treatments to those same treatments plus suzetrigine. Suitable participants include those who have undergone major surgeries, such as hip or knee replacements, and are at high risk of needing long-term opioids. As a Phase 4 trial, suzetrigine has already received FDA approval and proven effective; this research aims to understand its benefits for a broader patient population.

Do I need to stop 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 a fentanyl patch, methadone, or buprenorphine.

What is the safety track record for suzetrigine?

Research has shown that suzetrigine is generally safe and well-tolerated in people. One study found that suzetrigine effectively managed moderate to severe sudden pain, with most patients experiencing good to excellent results. Importantly, the safety review identified no serious side effects linked to its use. Another study highlighted that suzetrigine does not carry the risks associated with opioids, such as addiction or breathing problems, and it also avoids the kidney and stomach bleeding risks linked to NSAIDs (non-steroidal anti-inflammatory drugs). These findings suggest that suzetrigine offers a promising option for pain relief without the usual side effects of traditional pain medications.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for postoperative pain, which typically include opioids, NSAIDs, and acetaminophen, Suzetrigine is unique because it targets the Nav1.8 sodium channel in peripheral pain-sensing nerves. This selective sodium channel blocker is the first new class of pain medication in decades. What makes Suzetrigine truly exciting is that it doesn’t carry the risks associated with opioids, like respiratory depression and addiction, nor does it have the kidney or gastrointestinal risks linked with NSAIDs. This means it could offer effective pain relief without the common side effects of current pain management options.

What is the effectiveness track record for suzetrigine in treating postoperative pain?

Research has shown that suzetrigine effectively manages pain after surgery. In one study, 90.9% of patients rated its effectiveness as excellent, very good, or good. In this trial, participants in one arm will receive suzetrigine alongside standard care. Suzetrigine blocks a specific part of the body's pain pathway, providing relief without the addiction risk associated with opioids. Another study found that patients taking suzetrigine experienced faster pain relief and had less nausea and vomiting compared to those taking a placebo. Overall, suzetrigine offers significant pain relief with fewer side effects than traditional pain medications like opioids.16789

Who Is on the Research Team?

RA

Rodney A Gabriel, MD, MAS

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults having orthopedic surgery who are at high risk of needing opioids for more than 3 months after their operation, as predicted by a special computer model using their health records.

Inclusion Criteria

I am having a major orthopedic, breast, gynecological, or abdominal surgery.
I am at least 18 years old.
Patients identified as high-risk for POU by SurgNet-POU predictive deep learning model with probability threshold > 0.25, screened prior to surgery using electronic health record data
See 1 more

Exclusion Criteria

Pregnancy
Incarceration
Patients with previous history of opioid use disorder
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard care or standard care combined with a 14-day regimen of suzetrigine

14 days
Daily medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and opioid consumption at multiple time points

3 months
Assessments at 7, 14, 30, and 90 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study compares standard pain care (usual opioid prescriptions) to standard care plus suzetrigine, a non-opioid pain medicine taken before and for 14 days after surgery. Participants are randomly assigned to one group or the other.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Suzetrigine + Standard Care (standard outpatient analgesic prescriptions per surgical team)Experimental Treatment1 Intervention
Group II: Standard Care AloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Wellcome Leap Inc.

Industry Sponsor

Trials
1
Recruited
150+

Citations

The effectiveness and value of suzetrigine for moderate ... - PMC

Patients receiving suzetrigine after bunionectomy showed delayed pain relief (longer time to a drop of ≥2 points on the NPRS) than observed in the ...

Promise and Practical Limits of Suzetrigine - Consult QD

Suzetrigine also showed faster time to perceptible pain relief (≥ 1-point reduction); greater responder rates at 12, 24 and 48 hours; and higher ...

Suzetrigine (VX-548) for Postoperative Pain

Of these participants, 182 (82.0%) rated Suzetrigine's effectiveness as good, very good, or excellent. This high satisfaction rate suggests that ...

Suzetrigine as a Non-Opioid Analgesic: Balancing Promise ...

Overall, 83.2% of subjects rated suzetrigine as providing “good” to “excellent” analgesia. Comparative Effectiveness. While the data show that ...

NCT07195669 | RCT: Suzetrigine vs Norco for Post-op Pain

This study aims to further evaluate the efficacy and safety of Journavx in managing post-operative pain after third molar removal and orthognathic surgery.

Suzetrigine: A Novel Non-Opioid Analgesic for Acute Pain ...

This review synthesizes current evidence on suzetrigine's mechanism of action, clinical efficacy, safety profile, and therapeutic potential.

The effectiveness and value of suzetrigine for moderate ...

We evaluated the efficacy and safety of suzetrigine in adults with moderate to severe acute pain against 4 treatment modalities.

Suzetrigine in moderate to severe acute pain: a profile of its use

After treatment, 83.2% of patients rated their perception of the effectiveness of suzetrigine in managing pain as good, very good, or excellent ...

Safety and efficacy of Suzetrigine (VX-548) for acute ...

Suzetrigine shows strong efficacy and a favorable safety profile in acute post-surgical and neuropathic pain. •. Suzetrigine significantly reduces the risk of ...