NCT07534709

Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

Suzetrigine Versus Placebo for Opioid-Free Recovery After Cesarean Delivery: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 secure electronic system. Participants, clinicians, investigators, and study personnel are blinded to treatment assignment. The intervention consists of oral suzetrigine administered in the immediate postoperative period, beginning with a loading dose within 90 minutes after skin closure, followed by scheduled maintenance dosing every 12 hours. Participants randomized to the control arm receive a matching placebo on the same schedule. Study medication is prepared and dispensed by the investigational pharmacy in identical packaging to maintain blinding. All participants receive standardized multimodal postoperative analgesia consistent with institutional enhanced recovery pathways, including scheduled acetaminophen and non-steroidal anti-inflammatory drugs, as well as neuraxial morphine administered intraoperatively. Opioid medications remain available for breakthrough pain at the discretion of the clinical care team. Suzetrigine is a selective NaV1.8 voltage-gated sodium channel inhibitor that targets peripheral nociceptive pathways and does not act on opioid receptors. This study evaluates its use as an adjunct to standard multimodal analgesia in a postpartum surgical population in which opioid exposure remains common despite guideline-recommended care. Participants are followed during their inpatient hospitalization and through the early postpartum period using a combination of electronic medical record data and structured follow-up assessments to capture medication use, recovery, and patient-reported outcomes. Data are recorded using secure electronic data capture systems with predefined data fields and standardized collection procedures. Analyses will be conducted using an intention-to-treat approach, with comparisons between randomized groups based on pre-specified analytical methods appropriate for outcome type. Participant safety is monitored throughout the study period through routine clinical care, structured follow-up assessments, and oversight by an independent data safety monitoring board.

Conditions

• Cesarean Delivery
• Cesarean Section
• Pain, Postoperative
• Opioid Consumption, Postoperative

Interventions

Type	Name	Description
DRUG	Suzetrigine	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.
DRUG	Placebo	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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-02-01
• Completion: 2028-05-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study