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?

Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.

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+