Suzetrigine for Postoperative Pain

AL
CG
Overseen ByCindy Gu, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: University of California, Los Angeles
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 aims to determine if a pain relief plan using suzetrigine can control pain after transvaginal pelvic reconstructive surgery as effectively as the usual care, which includes opioids. Suzetrigine targets pain signals outside the brain, potentially resulting in fewer side effects compared to opioids. Participants will receive either suzetrigine with other non-opioid painkillers or the standard treatment, which includes opioids if needed. This study is suitable for adults undergoing this type of surgery who do not regularly use opioids or have certain chronic pain conditions. As a Phase 4 trial, this research seeks to understand how the already FDA-approved suzetrigine benefits more patients.

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 use strong CYP3A4 inhibitors within 7 days before surgery or if you have chronic opioid use.

What is the safety track record for suzetrigine?

Research has shown that suzetrigine is generally well-tolerated by patients. In one study, 90.9% of patients rated suzetrigine's effectiveness as excellent, very good, or good, indicating that most found it effective without major issues. Another study found that 90.9% of patients recovered without needing opioids, which often cause side effects.

These studies also demonstrated that suzetrigine provided reliable pain relief without the neurological side effects associated with opioids. There was no significant increase in unwanted side effects, suggesting the treatment is safe for most people. This is promising for those considering participation in a trial with suzetrigine.12345

Why are researchers enthusiastic about this study treatment?

Suzetrigine is unique because it is part of a multimodal approach that could reduce reliance on opioids for managing postoperative pain. While standard care often includes opioids, which can be addictive and have several side effects, suzetrigine offers a different strategy by being administered as a loading dose followed by a consistent dosing schedule with acetaminophen and ibuprofen. Researchers are excited about suzetrigine as it may provide effective pain relief with fewer side effects and lower risk of addiction compared to traditional opioid-inclusive regimens.

What evidence suggests that suzetrigine might be an effective treatment for postoperative pain?

Research has shown that suzetrigine is a promising non-opioid option for managing post-surgical pain. In earlier studies, 90.9% of patients rated the pain relief from suzetrigine as excellent or good, with many recovering without needing opioids. This trial will compare a suzetrigine-based regimen to a standard opioid-inclusive analgesic regimen. Suzetrigine blocks certain pain pathways, reducing pain without the usual side effects of opioids. Data from past trials indicate that suzetrigine effectively controls pain after various surgeries, such as bunion removal and plastic surgery. Overall, suzetrigine has proven safe and effective in providing pain relief while reducing the need for opioids.12467

Who Is on the Research Team?

AL

A Lenore Ackeman, MD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) having planned transvaginal pelvic reconstructive surgery at UCLA, who can give written consent and are expected to go home the same day or after a short stay.

Inclusion Criteria

I am 18 years old or older.
I am having planned transvaginal pelvic surgery at UCLA with a short hospital stay.
* Able to provide written informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either suzetrigine or standard opioid-inclusive postoperative care according to a stepped-wedge randomization schedule. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days.

1 week
Daily visits for medication administration

Follow-up

Participants are monitored for pain intensity, opioid consumption, adverse events, and functional recovery at 48 hours, 1 week, and 6 weeks postoperatively.

6 weeks
3 visits (in-person or virtual) at 48 hours, 1 week, and 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study compares pain control using suzetrigine (a new non-opioid pain medicine), acetaminophen, and ibuprofen versus standard care that includes opioids like tramadol or oxycodone. Participants are randomly assigned to different treatment groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Suzetrigine-Based RegimenExperimental Treatment2 Interventions
Group II: Standard Opioid-Inclusive Analgesic RegimenActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41222511/

Efficacy and Safety of Suzetrigine for Acute Postoperative ...

These findings suggest that suzetrigine offers effective and well-tolerated analgesia, supporting its role in opioid-sparing postoperative pain ...

Pain Suzetrigine Data Reveal Reduced Postoperative ...

The results revealed 90.9% of patients rated the effectiveness of suzetrigine as excellent, very good, or good (95% CI, 83.1%-95.7%), while ...

The effectiveness and value of suzetrigine for moderate ...

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

Data Support Suzetrigine's Use for Acute Pain Following ...

Phase 4 data show suzetrigine controls post–plastic surgery pain, keeping nearly 91% of patients opioid free with good pain ratings and ...

Association of Suzetrigine With Postoperative Outcomes ...

A novel non-opioid analgesic, Suzetrigine, may be able to effectively manage postoperative pain without some of the psychological and economic ...

Pain Suzetrigine Data Reveal Reduced Postoperative ...

SALT LAKE CITY—New data show that suzetrigine (Journavx, Vertex) results in opioid-free recovery for 90.9% of patients treated with the nonopioid inhibitor ...

Clinical Efficacy and Safety Profile of Suzetrigine: A Novel Non ...

These randomized, double-blind studies assessed the analgesic efficacy of suzetrigine in postoperative pain management following bunionectomy ...