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NOT YET RECRUITING
NCT07856654
PHASE4

Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management

Sponsor: Aditi Talkad

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-11

Completion Date

2028-05

Last Updated

2026-10-02

Healthy Volunteers

Yes

Interventions

DRUG

Suzetrigine

Suzetrigine (JOURNAVX), an oral, first-in-class, selective NaV1.8 inhibitor, administered as a 100 mg (2-tablet) loading dose on the evening of surgery, followed by 50 mg every 12 hours for 7 days, in addition to standard postoperative multimodal analgesia (scheduled ibuprofen and acetaminophen for the first 48 hours). Suzetrigine is FDA-approved for moderate-to-severe acute pain and provides peripheral analgesia without opioid-related CNS effects.

DRUG

Placebo

Placebo, matched in appearance to suzetrigine and formulated by the site's investigational pharmacy, administered as a 2-tablet loading dose on the evening of surgery, followed by 1 tablet every 12 hours for 7 days, in addition to standard postoperative multimodal analgesia (scheduled ibuprofen and acetaminophen for the first 48 hours).

Locations (1)

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

Austin, Texas, United States