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Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery

ConditionsPelvic Organ Prolapse (POP)Stress Urinary Incontinence (SUI)Postoperative Pain
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, Los Angeles

About this trial

Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.

Able to provide written informed consent.

Disqualifiers

Chronic opioid use.

Liver failure.

End-stage renal disease (ESRD).

Contraindication to acetaminophen or ibuprofen.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Suzetrigine

    Drug

    Loading dose: 100 mg orally on the morning of surgery Maintenance dose: 50 mg orally every 12 hours for 7 days Co-administered medications: Scheduled acetaminophen and ibuprofen Mechanism: Selective NaV1.8 sodium channel inhibitor acting on peripheral nociceptive neurons Purpose: Opioid-sparing postoperative analgesia

  • Opioid Analgesics (Tramadol or Oxycodone)

    Drug

    Tramadol: 50 mg orally every 4-6 hours as needed OR Oxycodone: 5 mg orally every 4-6 hours as needed Co-administered medications: Scheduled acetaminophen and ibuprofen Purpose: Standard postoperative analgesia per institutional protocol

  • Scheduled Acetaminophen and Ibuprofen

    Drug

    Participants in both study arms will receive scheduled acetaminophen and ibuprofen as part of standard multimodal postoperative analgesia. These medications are administered routinely following transvaginal pelvic reconstructive surgery to reduce baseline pain, minimize opioid requirements, and support enhanced recovery.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Suzetrigine-Based RegimenExperimental treatment 2 interventions
Group B: Standard Opioid-Inclusive Analgesic RegimenActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Pain intensity (0-10 NRS) at 48 hours postoperatively

Patient-reported postoperative pain intensity measured using the 0-10 Numerical Rating Scale (NRS).

Time frame
48 hours postoperatively

Secondary outcomes

1

Pain Intensity at 1 Week

Patient-reported pain intensity using the 0-10 NRS.

Time frame
1 week after surgery
2

Time to Rescue Analgesia in PACU

Time from arrival in the post-anesthesia care unit to first administration of rescue analgesic medication.

Time frame
During stay in post-anesthesia care unit, measured in hours up to 23 hours
3

Post-Discharge Opioid Use

Total opioid consumption after discharge, measured in morphine milligram equivalents (MME).

Time frame
Postoperative days 0-7
4

Post-Discharge Gabapentin Use

Any gabapentin or pregabalin use after discharge.

Time frame
Postoperative days 0-7

Other outcomes

Sponsors and contacts

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

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov

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