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

NCT ID: NCT07334418

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2027-11-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

General anesthesia

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

Group Type: ACTIVE_COMPARATOR

General anesthetic

Intervention Type: DRUG

standard of care general anesthesia

Intravenous sedation

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

Group Type: ACTIVE_COMPARATOR

Intravenous anesthetic

Intervention Type: DRUG

standard of care intravenous anesthesia

Interventions

General anesthetic

standard of care general anesthesia

Intervention Type: DRUG

Intravenous anesthetic

standard of care intravenous anesthesia

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Mark Neuman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mark Neuman, MD

Role: CONTACT

eagletadmin@pennmedicine.upenn.edu

215-746-7468

Other Identifiers

859498

Identifier Type: -

Identifier Source: org_study_id