Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management

NCT07856654 — Phase 4, Not yet recruiting, 48 participants, Aditi Talkad
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RegistryNCT07856654, acronym SUSI
StatusNot yet recruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment48 (Estimated)
SponsorAditi Talkad (Other)
ConditionsPelvic Organ Prolapse (POP), Postoperative Pain, Urogynecology
InterventionsSuzetrigine, Placebo (Drug)
Datesstart 2026-11-01 (estimated), primary completion 2027-12-01 (estimated), completion 2028-05-01 (estimated), first posted 2026-10-02, last updated 2026-10-02
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Pelvic Organ Prolapse (POP) All trials for Postoperative Pain All trials of Suzetrigine All trials of Placebo

-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.

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+Detailed 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 will enroll participants in a 1:1 ratio and assess pain, opioid consumption, adverse events, and patient-reported recovery over 7 days postoperatively.

+Arms and interventions

ArmTypeInterventionsDescription
Experimental GroupExperimentalDrug: SuzetrigineParticipants will receive suzetrigine 100 mg (2 tablets) as a loading dose on the evening of surgery, followed by 50 mg every 12 hours for 7 days, in addition to standard multimodal analgesia. Standard analgesia consists of ibuprofen 600 mg every 6 hours and acetaminophen 650 mg every 6 hours, scheduled for the first 48 hours postoperatively, after which patients may transition to as-needed dosing of both. An opioid prescription will be sent if triggered by previously set score and based on the patient's reported pain score.
Control GroupExperimentalDrug: PlaceboParticipants will receive matching placebo as a loading dose (2 tablets) on the evening of surgery, followed by 1 tablet every 12 hours for 7 days, in addition to standard multimodal analgesia. Standard analgesia consists of ibuprofen 600 mg every 6 hours and acetaminophen 650 mg every 6 hours, scheduled for the first 48 hours postoperatively, after which patients may transition to as-needed dosing of both. An opioid prescription will be sent if triggered by the patient's reported pain score.
  • Suzetrigine (Drug), also known as Experimental Group: 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.
  • Placebo (Drug), also known as Control Group: 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).

+Outcome measures

Primary outcomes

  • Postoperative Pain Score [Baseline (preoperative) to 7 days postoperatively]: Postoperative pain will be assessed using the Visual Analog Scale with change from baseline compared between patients receiving adjunctive suzetrigine versus standard multimodal postoperative pain management alone. This will assessed on a daily survey postoperatively.

Secondary outcomes

  • Cumulative Postoperative Opioid Consumption [7 days postoperatively]: Total opioid consumption, measured in morphine milligram equivalents (MME), will be assessed via daily patient-reported surveys collected through postoperative day 7 and compared between patients receiving suzetrigine versus placebo groups.
  • Patient-Reported Outcomes and Satisfaction With Postoperative Recovery [7 days postoperatively]: Patient-perceived control over pain management will be assessed using selected items from the American Pain Society Patient Outcome Questionnaire-Revised (APS-POQ-R), adapted for outpatient use following discharge.
  • Treatment Tolerability [7 days postoperatively]: Treatment tolerability, including incidence of side effects, will be assessed via daily patient-reported surveys collected through postoperative day 7 and compared between patients receiving suzetrigine versus placebo.

+Eligibility

Sex: Female, ages: 40 Years to 80 Years, accepts healthy volunteers

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 3 months prior to surgery, or current treatment for opioid use disorder.

  * Any opioid use within 30 days prior to the scheduled procedure date.
  * Significant hepatic disease, defined as AST or ALT >3 times the upper limit of normal or Child-Pugh class B or C.
  * Diagnosis of chronic pain syndrome or fibromyalgia
  * Inability to provide written informed consent
  * History of significant respiratory, cardiovascular, metabolic, neurologic, or psychiatric disease as deemed clinically significant by study team
  * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years or QT prolongation (QTcF >450 ms) or pacemaker/ICD
  * Severe kidney disease define as Estimated glomerular filtration rate (eGFR) of ≤ 30ml/min
  * Inability to receive or respond to text messages via mobile phone
  * Receives transversus abdominis plane (TAP) block
  * Allergy to any of the study medications
  * Use of moderate or strong CYP3A inducers or inhibitors, including prescription medications, over-the-counter medications, and herbal supplements known to significantly affect CYP3A metabolism (e.g., ketoconazole, clarithromycin, rifampin, carbamazepine, phenytoin, ritonavir, and St. John's Wort).
  * Pregnant or breastfeeding or planning to become pregnant within 30 days following last dose of study drug

+Locations (1)

FacilityCityCountryStatus
University of Texas at Austin Dell Medical School, Department of Women's HealthAustin, TexasUnited States

+Publications

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+Investigators

  • Amanda White, MD, Principal investigator, University of Texas at Austin Dell Medical School, Department of Women's Health