Health TrialsbyHealthPanel

Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management

ConditionsPelvic Organ Prolapse (POP)Postoperative PainUrogynecology
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40-80
SponsorAditi Talkad

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women ≥ 40 years and ≤ 80

BMI >=18.0 and <= 40.0

Can read and speak English or Spanish

Robotic-assisted laparoscopic sacrocolpopexy

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suzetrigine

    Drug

    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

    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).

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain Score

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.

Time frame
Baseline (preoperative) to 7 days postoperatively

Secondary outcomes

1

Cumulative Postoperative Opioid Consumption

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.

Time frame
7 days postoperatively
2

Patient-Reported Outcomes and Satisfaction With Postoperative Recovery

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.

Time frame
7 days postoperatively
3

Treatment Tolerability

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.

Time frame
7 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aditi Talkad

Lead sponsor

University of Texas at Austin

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: