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Suzetrigine for Opioid-Free Recovery After Cesarean Delivery

NCT07534709 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-04-16

No results posted yet for this study

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

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Lorie M. Harper, MD, MSCI · Dell Medical School, University of Texas at Austin, Department of Women's Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-02-29
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07534709 on ClinicalTrials.gov