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NOT YET RECRUITING
NCT07600697
PHASE4

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

Sponsor: University of California, Los Angeles

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-11-01

Completion Date

2028-07-01

Last Updated

2026-09-15

Healthy Volunteers

No

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.

Locations (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, United States