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

EAGLET-CS Pilot: 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cesarean Section; Delivery; Trauma
• Intervention / Treatment: Drug: General anesthetic; Drug: Intravenous anesthetic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Neuman, MD; Phone Number: 215-746-7468; Email: eagletadmin@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General anesthesia; Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement.	Drug: General anesthetic; standard of care general anesthesia
Active Comparator: Intravenous sedation; Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists.	Drug: Intravenous anesthetic; standard of care intravenous anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients meeting all inclusion criteria out of all screened	Percentage of patients meeting all inclusion criteria out of all screened	From hospital admission through day of delivery
Randomization	Percentage of consenting patients who undergo study randomization	From hospital admission through day of delivery
Quality of postoperative recovery	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.	Postoperative day 0, 1, 2, or 3
Satifaction with anesthesia	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.	Postoperative day 0, 1, 2, or 3
Severity and duration of pain	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.	Postoperative day 0, 1, 2, or 3
Adverse events	Postoperative serious adverse events via chart review	Randomization through postoperative day 30
Length of stay	Post-randomization hospital length of stay via chart review	Randomization through postoperative day 30
Need for intensive care	Need for maternal intensive care via chart review	Randomization through postoperative day 30
New PTSD (Posttraumatic Stress Disorder) symptoms	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.	Postoperative 6 week

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Cesarean Section; C-section; Delivery; Trauma
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Central Nervous System Agents; Anesthetics, General; Anesthetics, Intravenous
• Other Study ID Numbers: 859498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No