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

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.

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.

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.