Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

{ "Suzetrigine for Opioid-Free Recovery After Cesarean Delivery", "This study is testing whether a medication called suzetrigine can help women avoid using opioid pain medicines after a C-section (cesarean delivery). Researchers want to see if suzetrigine, when added to standard pain relief like acetaminophen and NSAIDs, increases the number of women who don't need any opioids for the first 72 hours after surgery. You could be eligible if you are at least 18 years old, having a C-section with neuraxial anesthesia (like a spinal or epidural), and can give informed consent. The study compares suzetrigine to a placebo (an inactive substance that looks like the real drug) to see if it helps you stay opioid-free.", "design": "This is a randomized, double-blind, placebo-controlled study involving about 90 participants. You would be randomly assigned to receive either suzetrigine or a placebo, and neither you nor your doctors would know which one you are receiving.", "commitments": "You would receive the study medication (either suzetrigine or placebo) orally after your C-section, starting within 90 minutes of surgery and continuing every 12 hours.", "compensation": "Not stated in the trial record.", "follow_up": "The main goal is measured up to 72 hours after your C-section.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

Not Yet Recruiting

PHASE4Ages 18+InterventionalTreatment

University of Texas at Austin

~90 participants

Updated 2026-04-16 on ClinicalTrials.gov

What's tested:SuzetriginePlacebo

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Proportion of Participants Remaining Opioid-Free Through 72 Hours Postoperatively

Measured over From completion of surgery to 72 hours postoperatively

Conditions

Cesarean Delivery

Cesarean Section

Pain, Postoperative

Opioid Consumption, Postoperative

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Lorie M. Harper, MD, MSCI · STUDY_DIRECTOR · Dell Medical School, University of Texas at Austin, Department of Women's Health

Who to contact

Chase Calvert, MD

[email protected]

512-771-0773

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.

What this trial measures

Proportion of Participants Remaining Opioid-Free Through 72 Hours PostoperativelyFrom completion of surgery to 72 hours postoperatively
Proportion of participants who do not receive any opioid medications from completion of cesarean delivery through 72 hours postoperatively.

Trialytics