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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Suzetrigine
DrugOral suzetrigine administered following cesarean delivery as an adjunct to standardized multimodal postoperative analgesia, including scheduled acetaminophen and nonsteroidal anti-inflammatory drugs, with opioid medications available as needed for breakthrough pain.
Placebo
DrugMatching oral placebo administered following cesarean delivery in addition to standardized multimodal postoperative analgesia, including scheduled acetaminophen and nonsteroidal anti-inflammatory drugs, with opioid medications available as needed for breakthrough pain.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: SuzetrigineExperimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of Participants Remaining Opioid-Free Through 72 Hours Postoperatively
Proportion of participants who do not receive any opioid medications from completion of cesarean delivery through 72 hours postoperatively.
Time frame
From completion of surgery to 72 hours postoperativelySecondary outcomes
1
Postoperative Pain Intensity Scores
Patient-reported pain intensity measured using the Numeric Rating Scale (NRS) for pain, an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores represent greater pain intensity.
Time frame
During hospitalization through 72 hours postoperatively2
Maternal Satisfaction With Pain Management
Participant-reported satisfaction with postoperative pain management assessed using a single-item Likert-type scale ranging from 0 to 10, where 0 indicates completely dissatisfied and 10 indicates completely satisfied. Higher scores indicate greater satisfaction.
Time frame
At hospital discharge and postoperative day 143
Functional Recovery After Cesarean Delivery
Functional recovery assessed using the Obstetric Quality of Recovery-11 (ObsQoR-11) questionnaire, a validated 11-item patient-reported outcome measure evaluating multiple domains of postoperative recovery, including pain, physical comfort, functional independence, and ability to care for the newborn. Each item is scored on an 11-point numeric scale (0-10), with total scores ranging from 0 to 110. Higher scores indicate better overall recovery.
Time frame
Postoperative day 74
Post-Discharge Opioid Use
Participant-reported opioid use after hospital discharge, including total quantity of opioid medications used, collected via structured self-report and expressed as number of tablets consumed or morphine milligram equivalents (MME) when available.
Time frame
From hospital discharge through postoperative day 14Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: