What this study is
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.
What's being tested
- Suzetrigine
Intervention · 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)
Intervention · 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
Intervention · 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.
Study details
- Sponsor
- University of California, Los Angeles
- Conditions
- Pelvic Organ Prolapse (POP) · Stress Urinary Incontinence (SUI) · Postoperative Pain
- Enrolling
- 120 people
- Starts
- 2026-11-01
- Est. completion
- 2028-07-01
- Design
- Single-blind, randomized, sequential groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of California, Los Angeles (UCLA)
Los Angeles, California, United States
Study team
Sponsor
University of California, Los Angeles
Study ID 26-0498
Principal investigator
A Lenore Ackeman, MD, PhD
University of California, Los Angeles
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.