600 Participants NeededMy employer runs this trial

Early General Anesthesia for PTSD During Cesarean Section

(EAGLET-CS Trial)

MN
Overseen ByMark Neuman, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the best way to prevent PTSD (post-traumatic stress disorder) symptoms in women experiencing severe pain during a cesarean section. It compares two methods: general anesthesia, which induces complete unconsciousness, and intravenous sedation, which reduces pain and anxiety but may require switching to general anesthesia if ineffective. Women eligible for this trial are those undergoing a planned cesarean section and experiencing severe pain unrelieved by standard pain treatments. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving pain management during cesarean sections.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that general anesthesia for C-sections is usually safe, but some risks exist. One study found it effective for these surgeries, though it might increase the risk of postpartum depression and affect mother-baby bonding. Another study found a link between general anesthesia and a higher chance of postpartum depression requiring hospital treatment. These studies highlight possible mental health effects after surgery.

For intravenous anesthesia, drugs like dexmedetomidine may help lower the risk of post-traumatic stress disorder in trauma situations. Both anesthesia methods have pros and cons, so discussing the risks and benefits with a healthcare provider is important before making a decision.12345

Why are researchers excited about this trial?

Unlike the standard treatments for PTSD, which typically involve psychotherapy or oral medications like SSRIs, this approach explores the use of anesthesia during cesarean sections. Researchers are excited about this method because it could offer immediate relief from PTSD symptoms by preventing the formation of traumatic memories during childbirth. Additionally, the use of general anesthesia provides a unique opportunity to induce a state of unconsciousness, potentially interrupting the stress response pathways linked to PTSD. This could lead to a novel way of addressing PTSD symptoms in a very specific and time-sensitive context.

What evidence suggests that this trial's treatments could be effective for preventing PTSD during cesarean sections?

This trial will compare the effects of general anesthesia and intravenous anesthesia on the risk of developing PTSD after a C-section. Research has shown that general anesthesia, which induces complete unconsciousness, might lead to higher rates of postpartum depression and PTSD compared to other methods. In contrast, intravenous anesthesia, which involves administering medication through an IV to manage pain and anxiety, has shown mixed results. Some evidence suggests that certain IV medications may help reduce PTSD symptoms in trauma situations. However, more research is needed to determine the effectiveness of both methods in preventing PTSD specifically after a C-section.56789

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older having a planned (non-emergency) C-section with spinal or epidural anesthesia, who experience severe pain during surgery that doesn't improve after two rounds of standard pain medicine.

Inclusion Criteria

I am a woman 18 or older having a planned C-section with spinal or epidural anesthesia and had severe pain during surgery that did not improve after two rounds of standard pain medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

From hospital admission through day of delivery

Treatment

Participants receive either early conversion to general anesthesia or a time-limited trial of intravenous sedation, followed by conversion to general anesthesia if needed

During cesarean section

Follow-up

Participants are monitored for safety, mental health, medical, and quality of recovery outcomes after treatment

Up to 6 weeks after delivery

What Are the Treatments Tested in This Trial?

Interventions

  • General anesthetic
  • Intravenous anesthetic

Trial Overview

The study compares two ways to manage severe pain during C-section: switching to full general anesthesia (making the patient fully unconscious) versus giving intravenous medications to reduce pain and anxiety. Participants are randomly assigned to one of these options.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Intravenous sedationActive Control1 Intervention
Group II: General anesthesiaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Citations

Post-traumatic stress disorder in parturients delivering ... - PMC

This is the first study to show in parturients having a C-section that an anaesthesia complication is an independent risk factor for postpartum PTSD and PTSD ...

Prevalence and correlates of postpartum PTSD following ...

The prevalence of PTSD following emergency C-sections ranged from 2.2 to 41.2%, compared to 0–20% in elective cesarean sections.

Emergency cesarean section and mental health

Results: Results showed a high prevalence of postpartum PTSD (31.7%) and PTSD profile (14.3%) in women after emergency caesarean section with additional risk ...

Statement on Providing Psychological Support for Obstetric ...

Childbirth-related posttraumatic stress disorder (CR-PTSD) impacts up to 6% of postpartum patients with 12.3% reporting posttraumatic stress.

The impact of General Anaesthetic Caesarean Section on ...

Findings indicated an increased risk of postpartum depression, birth dissatisfaction and impaired maternal-infant bonding for GACS compared to neuraxial ...

Exposure to general anesthesia for cesarean delivery and ...

General anesthesia for cesarean delivery is associated with increased odds of severe PPD requiring hospitalization, suicidal ideation, and self-inflicted ...

Pain during a C-section? New study challenges fears ...

Data analyzed by Penn researchers clarifies risks associated with general anesthesia during C-section, giving patients more control over ...

General anesthesia found safe and effective for cesarean ...

A study found that general anesthesia during c-section is both safe and effective, challenging long-held concerns about newborn health.

Pain During Cesarean Delivery—Improving Patient Safety ...

Research now demonstrates that birth trauma, including PDCD, may lead to real short- and long-term psychological damage. Post-traumatic stress ...