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NCT Number: NCT07334418

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

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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Key information

Conditions

Cesarean Section Delivery; Trauma Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Mark Neuman

CONTACT

[email protected]

2156624000

About this study

The EAGLET-CS Pilot is a randomized trial that will assess the feasibility of comparing two commonly used approaches to care for women undergoing cesarean delivery under standard neuraxial anesthesia (epidural, spinal, or CSE) who experience intraoperative pain after delivery that is refractory to first line treatments. 12 patients recruited from the labor and delivery service at the Hospital of the University of Pennsylvania will be assigned to one of two standard-care comparators, namely early conversion to general anesthesia versus a time-limited trial of intravenous sedation, followed by conversion to general anesthesia if needed due to ongoing pain. Patients will be assessed during hospitalization and at up to 6 weeks after delivery to assess mental health, medical, and quality of recovery outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General anesthetic

Other

standard of care general anesthesia

Intravenous anesthetic

Other

standard of care intravenous anesthesia

Primary outcomes

  1. Consent

    Time frame: From hospital admission through day of delivery

    Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment.

Secondary outcomes

  1. Percentage of patients meeting all inclusion criteria out of all screened

    Time frame: From hospital admission through day of delivery

    Percentage of patients meeting all inclusion criteria out of all screened

  2. Randomization

    Time frame: From hospital admission through day of delivery

    Percentage of consenting patients who undergo study randomization

  3. Quality of postoperative recovery

    Time frame: Postoperative day 0, 1, 2, or 3

    Quality of postoperative recovery via 11-item Obstetric Quality of Recovery Scoring Tool minimum score 0 and maximum score 110. A higher score means better.

  4. Satifaction with anesthesia

    Time frame: Postoperative day 0, 1, 2, or 3

    Satisfaction with anesthesia care via 11-item Obstetric Quality of Recovery Scoring Tool minimum score 0 and maximum score 110. A higher score means better.

  5. Severity and duration of pain

    Time frame: Postoperative day 0, 1, 2, or 3

    Reported severity and duration of pain during surgery via 5-item SONAR (Snapshot Obstetric Anesthesia National Research Project) Maternal Comfort Scale. Minimum score 5 and Maximum score 35. A higher score means better.

  6. Adverse events

    Time frame: Randomization through postoperative day 30

    Postoperative serious adverse events via chart review

  7. Length of stay

    Time frame: Randomization through postoperative day 30

    Post-randomization hospital length of stay via chart review

  8. Need for intensive care

    Time frame: Randomization through postoperative day 30

    Need for maternal intensive care via chart review

  9. New PTSD (Posttraumatic Stress Disorder) symptoms

    Time frame: Postoperative 6 week

    New PTSD (Posttraumatic Stress Disorder) symptoms at 6 weeks after delivery via PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-5) Minimum score 0 and maximum score 80. A higher score means worse.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Neuman, MD

CONTACT

[email protected]

215-746-7468

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: EAGLET-CS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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