A Phase 4 interventional study of Suzetrigine and Opioid Analgesics (Tramadol or Oxycodone) in Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI) and Postoperative Pain, sponsored by University of California, Los Angeles. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Fibromyalgia Interstitial cystitis Chronic pelvic pain
Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen.
Drug: Suzetrigine · Drug: Scheduled Acetaminophen and Ibuprofen
Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care.
Drug: Opioid Analgesics (Tramadol or Oxycodone) · Drug: Scheduled Acetaminophen and Ibuprofen
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
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
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.
Pain intensity (0-10 NRS) at 48 hours postoperatively
Patient-reported postoperative pain intensity measured using the 0-10 Numerical Rating Scale (NRS).
Time frame: 48 hours postoperatively
Pain Intensity at 1 Week
Patient-reported pain intensity using the 0-10 NRS.
Time frame: 1 week after surgery
Time to Rescue Analgesia in PACU
Time from arrival in the post-anesthesia care unit to first administration of rescue analgesic medication.
Time frame: During stay in post-anesthesia care unit, measured in hours up to 23 hours
Post-Discharge Opioid Use
Total opioid consumption after discharge, measured in morphine milligram equivalents (MME).
Time frame: Postoperative days 0-7
Post-Discharge Gabapentin Use
Any gabapentin or pregabalin use after discharge.
Time frame: Postoperative days 0-7
Constipation
Time to first bowel movement Additional bowel regimen use
Time frame: Up to 1 week postoperatively
Nausea and Vomiting
Incidence of postoperative nausea or vomiting reported by participants.
Time frame: Up to 1 week postoperatively
Dizziness or Lightheadedness
Incidence of postoperative dizziness or lightheadedness.
Time frame: Up to 1 week postoperatively
Time to Return to Driving
Number of days from surgery until the participant reports resuming driving.
Time frame: Up to 6 weeks
Time to Return to Work
Number of days from surgery until the participant reports returning to work.
Time frame: Up to 6 weeks
Postoperative Patient-Initiated Communication Burden
Number of patient-initiated messages, calls, or portal contacts related to postoperative pain or medication concerns.
Time frame: Up to 6 weeks
Plan to share: No — The investigators do not plan to share individual participant data (IPD). Due to the sensitive nature of postoperative clinical data and institutional policies regarding patient privacy, de-identified datasets will not be made available. Study findings will be disseminated through aggregate results posted on ClinicalTrials.gov and peer-reviewed publications.
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University of California, Los Angeles