MedTrace Logo

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

NCT07600697 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse (POP)
  • Stress Urinary Incontinence (SUI)
  • Postoperative Pain

Interventions

DRUG

Suzetrigine

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

DRUG

Opioid Analgesics (Tramadol or Oxycodone)

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

DRUG

Scheduled Acetaminophen and Ibuprofen

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.

Sponsors & Collaborators

Principal Investigators

  • A Lenore Ackeman, MD, PhD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2028-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07600697 on ClinicalTrials.gov