Suzetrigine for Postoperative Pain

(SUSI Trial)

AT
Overseen ByAditi Talkad MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Aditi Talkad
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?

The goal of this clinical trial is to determine whether suzetrigine, when added to standardized multimodal postoperative analgesia improves pain control and reduces opioid consumption after apical suspension surgery for pelvic organ prolapse.

Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome.

The main questions it aims to answer are:

* Does suzetrigine reduce postoperative pain scores compared to placebo?

* Does suzetrigine reduce the need for opioid rescue medication after surgery?

Researchers will compare participants receiving suzetrigine to participants receiving placebo, both on top of standard postoperative pain management, to see if suzetrigine lowers pain scores and opioid consumption after apical suspension surgery.

Who Is on the Research Team?

AW

Amanda White, MD

Principal Investigator

University of Texas at Austin Dell Medical School, Department of Women's Health

Are You a Good Fit for This Trial?

This trial is for adults having apical suspension surgery to treat pelvic organ prolapse. Participants must be able to follow study instructions and receive standard pain management after surgery.

Inclusion Criteria

BMI ≥18.0 and ≤ 40.0
Can read and speak English or Spanish
I am having major pelvic surgery for prolapse repair.
See 1 more

Exclusion Criteria

Pregnant or breastfeeding or planning to become pregnant within 30 days following last dose of study drug
I have significant liver disease or very high liver enzyme levels.
History of significant respiratory, cardiovascular, metabolic, neurologic, or psychiatric disease as deemed clinically significant by study team
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What Are the Treatments Tested in This Trial?

Interventions

  • Suzetrigine

Trial Overview

The study tests whether adding suzetrigine to usual pain medications helps control pain and reduces the need for opioids after pelvic organ prolapse surgery, compared to a placebo. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Experimental GroupExperimental Treatment1 Intervention
Group II: Control GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aditi Talkad

Lead Sponsor