New drug aims to keep new moms Opioid-Free after C-Section
NCT ID NCT07534709
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding suzetrigine to standard pain management helps more women stay completely opioid-free for the first 72 hours after a C-section. About 90 women having scheduled or unscheduled C-sections will receive either suzetrigine or a placebo, along with usual pain medicines. Opioids will still be available if needed for severe pain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas at Austin Dell Medical School, Department of Women's Health
Austin, Texas, 78705, United States
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Other studies related to the condition(s) this trial covers.
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- Can childbirth education cut unnecessary C-Sections?