Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

Starting soon · Phase 4 · Has a placebo group

Conditions studied: Cesarean Delivery, Cesarean Section, Pain, Postoperative, Opioid Consumption, Postoperative

In brief

The goal of this clinical trial is to determine whether suzetrigine increases the proportion of patients who remain completely opioid-free from completion of surgery through 72 hours after cesarean delivery. The main question it aims to answer is: Does adjunctive suzetrigine, when added to a standardized multimodal postoperative analgesic regimen, increase the proportion of patients who remain opioid-free during the first 72 hours after cesarean delivery? Researchers will compare suzetrigine to a placebo (a look-alike substance that contains no drug) to evaluate this outcome. Participants will: * Receive either suzetrigine or placebo after cesarean delivery * Receive standard postoperative pain management, including acetaminophen, nonsteroidal anti-inflammatory drugs, and neuraxial morphine * Have opioid medications available as needed for breakthrough pain * Be followed during hospitalization and after discharge to assess pain, recovery, and medication use

Key facts

Study ID

NCT07534709

Run by

University of Texas at Austin

People needed

90

Starts

2026-06-01

Expected to finish

2028-05-01

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women aged ≥18 years.
• Undergoing scheduled or unscheduled cesarean delivery during the current admission, with or without concomitant salpingectomy.
• Planned delivery under neuraxial anesthesia (spinal, epidural, or combined spinal-epidural).
• Planned Pfannenstiel skin incision.
• Able to provide informed consent in English or Spanish.
• Willing and able to complete required remote follow-up assessments through postoperative day 14 (POD14).

You may not qualify if…

• Planned provision of breast milk to the neonate during the period of suzetrigine exposure (while the study drug is being taken and for 96 hours after last dose), due to the absence of human lactation safety data for suzetrigine.*
• Known allergy, hypersensitivity, or contraindication to suzetrigine or any component of its formulation.
• Chronic opioid use, defined as daily opioid use for more than 7 consecutive days in the month prior to delivery, or current treatment for opioid use disorder.
• Significant hepatic disease, defined as AST or ALT >3 times the upper limit of normal or Child-Pugh class B or C.
• Severe renal impairment, defined as estimated glomerular filtration rate (eGFR) <15 mL/min.
• Concurrent use of medications known to significantly alter suzetrigine metabolism, including strong CYP3A inhibitors or inducers, such as:
• ketoconazole
• ritonavir
• carbamazepine
• rifampin
• St. John's wort (or other agents deemed clinically significant CYP3A modulators by the study investigator team)
• Planned cesarean delivery under general anesthesia without neuraxial anesthesia.
• Planned non-Pfannenstiel skin incision (e.g., vertical midline incision).
• Participation in another interventional pain-management clinical trial during the current hospitalization.
• Additional operative procedures (excluding salpingectomy) performed at the time of cesarean delivery (e.g., hysterectomy, hernia repair).
• Inability to provide informed consent or to complete required study procedures and follow-up.
• Receipt of opioid or sedating medications prior to completion of the informed consent process.
• Feeding decisions are made independently of study participation. The study does not require participants to alter infant feeding plans; eligibility is determined solely by whether breast milk will be provided to the neonate during the period of study drug exposure (while the study drug is being taken and for 96 hours after last dose). Participants who plan to breastfeed but independently elect not to provide breast milk to the neonate during the period of suzetrigine exposure are eligible.

Where it is running

• University of Texas at Austin Dell Medical School, Department of Women's Health — Austin, Texas, United States

Full record on ClinicalTrials.gov

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