Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management

Aditi Talkad

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.

Description

Suzetrigine is a first-in-class, selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. It was approved by the FDA in 2025 as a non-opioid alternative for moderate-to-severe pain following Phase 3 studies in abdominoplasty and bunionectomy. This single-center, randomized, double-blinded, placebo-controlled trial evaluates whether a suzetrigine-based postoperative analgesic regimen reduces opioid consumption and improves pain control compared with standard opioid-inclusive care following apical suspension surgery for pelvic organ prolapse. The study wi…

Eligibility

Age range: 40–80 years
Sex: Female
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: * Women ≥ 40 years and ≤ 80 * BMI \>=18.0 and \<= 40.0 * Can read and speak English or Spanish * Undergoing major urogynecologic surgery, defined as having at least one of the following: * Robotic-assisted laparoscopic sacrocolpopexy * Uterosacral ligament suspension (laparoscopic or vaginal approach) * Uterosacral hysteropexy * Sacrospinous hysteropexy * Sacrospinous ligament fixation * Conversion to laparotomy during primary surgery for prolapse repair Exclusion Criteria: * • Current narcotic use defined as daily use for more than 7 consecutive days in the…

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).

Location

University of Texas at Austin Dell Medical School, Department of Women's Health
Austin, Texas
aditi.talkad@ascension.org 404-434-3889

Summary

Description

Eligibility

Age range

40–80 years

Sex

Female

Healthy volunteers

Yes

Detailed criteria

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).