Pelvic Organ Prolapse (POP), Postoperative Pain, Stress Urinary Incontinence (SUI)
Conditions
Keywords
Suzetrigine, NaV1.8 Inhibitor, Non-opioid analgesic, pelvic reconstructive surgery, transvaginal surgery, postoperative pain, opioid-sparing analgesia, multimodal pain management, pelvic organ prolapse, randomized clinical trial, stepped-wedge design, phase 4 trial
Brief 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.
Detailed description
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.
Interventions
DRUGSuzetrigine
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
DRUGOpioid 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
DRUGScheduled 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
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
Treating surgeons will remain blinded to treatment allocation. Participants and study staff will not be blinded due to differences in medication appearance and administration.
Intervention model description
Stepped-wedge randomized design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (0-10 NRS) at 48 hours postoperatively | 48 hours postoperatively | Patient-reported postoperative pain intensity measured using the 0-10 Numerical Rating Scale (NRS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity at 1 Week | 1 week after surgery | Patient-reported pain intensity using the 0-10 NRS. |
| Time to Rescue Analgesia in PACU | During stay in post-anesthesia care unit, measured in hours up to 23 hours | Time from arrival in the post-anesthesia care unit to first administration of rescue analgesic medication. |
| Post-Discharge Opioid Use | Postoperative days 0-7 | Total opioid consumption after discharge, measured in morphine milligram equivalents (MME). |
| Post-Discharge Gabapentin Use | Postoperative days 0-7 | Any gabapentin or pregabalin use after discharge. |
| Constipation | Up to 1 week postoperatively | Time to first bowel movement Additional bowel regimen use |
| Nausea and Vomiting | Up to 1 week postoperatively | Incidence of postoperative nausea or vomiting reported by participants. |
| Dizziness or Lightheadedness | Up to 1 week postoperatively | Incidence of postoperative dizziness or lightheadedness. |
| Time to Return to Driving | Up to 6 weeks | Number of days from surgery until the participant reports resuming driving. |
| Time to Return to Work | Up to 6 weeks | Number of days from surgery until the participant reports returning to work. |
| Postoperative Patient-Initiated Communication Burden | Up to 6 weeks | Number of patient-initiated messages, calls, or portal contacts related to postoperative pain or medication concerns. |
Countries
United States
Contacts
CONTACTA Lenore Ackerman, MD, PhD
CONTACTCindy Gu, MD
PRINCIPAL_INVESTIGATORA Lenore Ackeman, MD, PhD
University of California, Los Angeles
Outcome results
None listed