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

NCT07334418 | Not Yet Recruiting

• 1 other identifier: 859498
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cesarean Section; Delivery; Trauma

Keywords

Cesarean Section; Delivery; Trauma; C-section; PTSD

Outcome Measures

Primary Outcomes (1)

• Consent

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

  From hospital admission through day of delivery

Secondary Outcomes (9)

• Percentage of patients meeting all inclusion criteria out of all screened

  From hospital admission through day of delivery

• Randomization

  From hospital admission through day of delivery

• Quality of postoperative recovery

  Postoperative day 0, 1, 2, or 3

• Satifaction with anesthesia

  Postoperative day 0, 1, 2, or 3

• Severity and duration of pain

  Postoperative day 0, 1, 2, or 3

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement.

Drug: General anesthetic

Intravenous sedation

ACTIVE COMPARATOR

Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists.

Drug: Intravenous anesthetic

Interventions

General anesthetic DRUG

standard of care general anesthesia

General anesthesia

Intravenous anesthetic DRUG

standard of care intravenous anesthesia

Intravenous sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• We will exclude patients who require induction of general anesthesia prior to umbilical cord clamping and by clinician determination.

Sponsors & Collaborators

• University of Pennsylvania: lead

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Interventions

Anesthetics, General; Anesthetics, Intravenous

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Mark Neuman, MD

CONTACT

215-746-7468; eagletadmin@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 12, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share