NCT07334418

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cesarean Section
• Delivery; Trauma

Interventions

Type	Name	Description
DRUG	General anesthetic	standard of care general anesthesia
DRUG	Intravenous anesthetic	standard of care intravenous anesthesia

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-01-12
• Last updated: 2026-01-15