Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone), Scheduled Acetaminophen and Ibuprofen.
- Who it may be relevant to
- Registry conditions: Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI), Postoperative Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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.
Primary outcome measures
- Pain intensity (0-10 NRS) at 48 hours postoperatively [Time frame: 48 hours postoperatively]
Secondary outcome measures (10)
- Pain Intensity at 1 Week [Time frame: 1 week after surgery]
- Time to Rescue Analgesia in PACU [Time frame: During stay in post-anesthesia care unit, measured in hours up to 23 hours]
- Post-Discharge Opioid Use [Time frame: Postoperative days 0-7]
- Post-Discharge Gabapentin Use [Time frame: Postoperative days 0-7]
- Constipation [Time frame: Up to 1 week postoperatively]
- Nausea and Vomiting [Time frame: Up to 1 week postoperatively]
- Dizziness or Lightheadedness [Time frame: Up to 1 week postoperatively]
- Time to Return to Driving [Time frame: Up to 6 weeks]
- Time to Return to Work [Time frame: Up to 6 weeks]
- Postoperative Patient-Initiated Communication Burden [Time frame: Up to 6 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, Los Angeles (UCLA) — Los Angeles
Publications
- Dong S, Zhong Y, Chu L, Li H, Tong X, Wang J. Age-stratified analysis of long-term outcomes of transvaginal mesh repair for treatment of pelvic organ prolapse. Int J Gynaecol Obstet. 2016 Oct;135(1):112-6. doi: 10.1016/j.ijgo.2016.03.031. Epub 2016 Jun 20. PMID 27392806
- Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0. PMID 17382829
- Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12. PMID 31201808
- Keam SJ. Suzetrigine: First Approval. Drugs. 2025 Jun;85(6):845-851. doi: 10.1007/s40265-025-02178-w. Epub 2025 May 5. PMID 40323340
- Ali MY, Antunes FTT, Huang S, Chen L, Zamponi GW. Pharmacological inhibition of NaV1.8 by suzetrigine reveals potent analgesic potential without tolerance development in mice. Mol Brain. 2025 Nov 13;18(1):86. doi: 10.1186/s13041-025-01253-3. PMID 41233910
- Stewart RG, Osorno T, Fujita A, Jo S, Ferraiuolo A, Carlin K, Bean BP. Modulation of human dorsal root ganglion neuron firing by the Nav1.8 inhibitor suzetrigine. Proc Natl Acad Sci U S A. 2025 Jun 3;122(22):e2503570122. doi: 10.1073/pnas.2503570122. Epub 2025 May 27. PMID 40424150
Identifiers
NCT: NCT07600697 · 26-0498