Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT07534709
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Suzetrigine — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
May 31, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suzetrigine
    Participants will receive oral suzetrigine 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.
  • Experimental: Placebo
    Participants will receive matching oral placebo 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.

Primary Outcome Measure

Proportion of Participants Remaining Opioid-Free Through 72 Hours Postoperatively [ Time Frame: From completion of surgery to 72 hours postoperatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas at Austin Dell Medical School, Department of Women's HealthAustinTexas78705
Chase Calvert, MD
[email protected]
5127710773
Lorie M Harper, MD, MSCI (PRINCIPAL_INVESTIGATOR)
Chase Calvert, MD (SUB_INVESTIGATOR)

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By research site
University of Texas at Austin Dell Medical School, Department of Women's Health· Austin, TX

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