Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around
Principal Investigator
by A Lenore Ackeman, MD, PhD (ucla)

Description

Summary

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.

Details

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.

Keywords

Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI), Postoperative Pain, Suzetrigine, NaV1.8 Inhibitor, Non-opioid analgesic, pelvic reconstructive surgery, transvaginal surgery, opioid-sparing analgesia, multimodal pain management, pelvic organ prolapse, randomized clinical trial, stepped-wedge design, phase 4 trial, Stress Urinary Incontinence, Opioid Analgesics, Tramadol, Oxycodone, Ibuprofen, Opioid Analgesics (Tramadol or Oxycodone), Scheduled Acetaminophen and Ibuprofen

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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.

Location

  • University of California, Los Angeles (UCLA)
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07600697
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated