Suzetrigine for Opioid-Free Recovery After Cesarean Delivery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Texas at Austin
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Suzetrigine
- Placebo
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov