Suzetrigine Versus Placebo for Opioid-Free Recovery After Cesarean Delivery: A Randomized Controlled Trial
University of Texas at Austin
Summary
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
Description
This is a single-site, randomized, double-blind, placebo-controlled clinical trial evaluating whether adjunctive suzetrigine increases the proportion of patients who remain opioid-free following cesarean delivery. The study is conducted at a tertiary care academic medical center. Participants undergoing cesarean delivery under neuraxial anesthesia are randomized in a 1:1 ratio to receive either oral suzetrigine or a matching placebo following surgery. Randomization is performed using a computer-generated sequence with permuted blocks of variable size and allocation concealment through a secur…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 stu…
Interventions
- DrugSuzetrigine
Oral 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.
- DrugPlacebo
Matching 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.
Location
- University of Texas at Austin Dell Medical School, Department of Women's HealthAustin, Texas