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.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Browse Pelvic Organ Prolapse studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Fibromyalgia Interstitial cystitis Chronic pelvic pain
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Suzetrigine
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