Phase 4 Suzetrigine Trial for Opioid-Free Cesarean Recovery
Summary
NIH registered Phase 4 clinical trial NCT07534709 to evaluate suzetrigine as an adjunctive analgesic for opioid-free recovery following cesarean delivery. The randomized, placebo-controlled study will assess whether suzetrigine added to standard multimodal analgesia increases the proportion of patients remaining opioid-free through 72 hours post-surgery. Participants receive standardized pain management with acetaminophen, NSAIDs, and neuraxial morphine, with opioid rescue medication available for breakthrough pain.
What changed
NIH registered a new Phase 4 clinical trial on ClinicalTrials.gov studying suzetrigine as an adjunctive analgesic for opioid-free cesarean delivery recovery. The randomized, double-blind, placebo-controlled study will evaluate whether suzetrigine added to a standardized multimodal analgesic regimen increases the proportion of patients remaining opioid-free during the first 72 hours post-cesarean. The trial plans to enroll participants receiving standard care including acetaminophen, NSAIDs, and neuraxial morphine.
Pharmaceutical companies and clinical research organizations conducting or sponsoring analgesic drug trials should note this trial design as an emerging model for evaluating opioid-sparing endpoints. Healthcare systems performing cesarean deliveries may want to monitor results, as findings could influence postoperative pain management protocols. The trial's focus on complete opioid avoidance aligns with broader efforts to reduce opioid exposure in obstetric populations.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Suzetrigine for Opioid-Free Recovery After Cesarean Delivery
Phase 4 NCT07534709 Kind: PHASE4 Apr 16, 2026
Abstract
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
Conditions: Cesarean Delivery, Cesarean Section, Pain, Postoperative, Opioid Consumption, Postoperative
Interventions: Suzetrigine, Placebo
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