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NCT Number: NCT07600697

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

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.

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Key information

Conditions

Pelvic Organ Prolapse (POP) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Postoperative Complications Postoperative Pain Prolapse Signs and Symptoms Stress Urinary Incontinence (SUI) Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

About this study

Suzetrigine has demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen in Phase III trials and is FDA-approved for acute pain. This trial represents the first evaluation of a NaV1.8 inhibitor in pelvic reconstructive surgery. Participants will receive either suzetrigine or standard opioid-inclusive postoperative care according to a stepped-wedge randomization schedule. Pain scores, medication use, and adverse events will be collected at 48 hours, 1 week, and 6 weeks postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Chronic opioid use.
  • Liver failure.
  • End-stage renal disease (ESRD).
  • Chronic pain syndromes, including:

Fibromyalgia Interstitial cystitis Chronic pelvic pain

  • Contraindication to acetaminophen or ibuprofen.
  • Use of strong CYP3A4 inhibitors within 7 days prior to surgery or anticipated need during the treatment period.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 48 hours postoperatively

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

Secondary outcomes

  1. Pain Intensity at 1 Week

    Time frame: 1 week after surgery

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

  2. Time to Rescue Analgesia in PACU

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

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

  3. Post-Discharge Opioid Use

    Time frame: Postoperative days 0-7

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

  4. Post-Discharge Gabapentin Use

    Time frame: Postoperative days 0-7

    Any gabapentin or pregabalin use after discharge.

  5. Constipation

    Time frame: Up to 1 week postoperatively

    Time to first bowel movement

    Additional bowel regimen use

  6. Nausea and Vomiting

    Time frame: Up to 1 week postoperatively

    Incidence of postoperative nausea or vomiting reported by participants.

  7. Dizziness or Lightheadedness

    Time frame: Up to 1 week postoperatively

    Incidence of postoperative dizziness or lightheadedness.

  8. Time to Return to Driving

    Time frame: Up to 6 weeks

    Number of days from surgery until the participant reports resuming driving.

  9. Time to Return to Work

    Time frame: Up to 6 weeks

    Number of days from surgery until the participant reports returning to work.

  10. Postoperative Patient-Initiated Communication Burden

    Time frame: Up to 6 weeks

    Number of patient-initiated messages, calls, or portal contacts related to postoperative pain or medication concerns.

Study contacts

Contact information is provided by the study sponsor or research team.

A Lenore Ackerman, MD, PhD

CONTACT

[email protected]

310-794-0206

Cindy Gu, MD

CONTACT

[email protected]

310-794-7700 ext. 35879

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 22, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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