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New drug aims to keep new moms Opioid-Free after C-Section

NCT ID NCT07534709

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.

Pain, Postoperative

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

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

    Austin, Texas, 78705, United States

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