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Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study

RecruitingNAAges 18 Years - anyFemaleUniversity of Pennsylvania
NCT07334418 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Some patients who undergo cesarean section under spinal or epidural anesthesia can experience severe pain. Some patients who experience this kind of pain can experience symptoms of post-traumatic stress disorder (PTSD) after pregnancy. Currently, the two main options for treating this pain are general anesthesia (full medically induced unconsciousness) and using intravenous medications to reduce the pain and decrease anxiety. The EAGLET-CS Pilot is a pilot randomized trial that will test the feasibility of comparing the impact of these two options for preventing PTSD in a rigorous way for those patients who experience pain during their cesarean section after the baby is out.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women aged 18 or older undergoing non-emergent cesarean delivery with primary neuraxial (epidural, spinal, or CSE) anesthesia. Eligible patients will be those who report severe pain during surgery, defined as pain that does not resolve with 2 trials of first-line pharmacologic therapies (e.g., epidural supplementation with local anesthetics; intravenous opioid analgesics). Exclusion Criteria: * We will exclude patients who require induction of general anesthesia prior to umbilical cord clamping and by clinician determination.
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What it tests

  • General anesthetic
  • Intravenous anesthetic
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Where

1 site
Hospital of the University of Pennsylvania
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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