Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: General anesthetic, Intravenous anesthetic.
- Who it may be relevant to
- Registry conditions: Cesarean Section, Delivery; Trauma. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EAGLET-CS Pilot: Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
Overview
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.
Interventions
- Other General anesthetic
standard of care general anesthesia - Other Intravenous anesthetic
standard of care intravenous anesthesia
Primary outcome measures
- Consent [Time frame: From hospital admission through day of delivery]
Secondary outcome measures (9)
- Percentage of patients meeting all inclusion criteria out of all screened [Time frame: From hospital admission through day of delivery]
- Randomization [Time frame: From hospital admission through day of delivery]
- Quality of postoperative recovery [Time frame: Postoperative day 0, 1, 2, or 3]
- Satifaction with anesthesia [Time frame: Postoperative day 0, 1, 2, or 3]
- Severity and duration of pain [Time frame: Postoperative day 0, 1, 2, or 3]
- Adverse events [Time frame: Randomization through postoperative day 30]
- Length of stay [Time frame: Randomization through postoperative day 30]
- Need for intensive care [Time frame: Randomization through postoperative day 30]
- New PTSD (Posttraumatic Stress Disorder) symptoms [Time frame: Postoperative 6 week]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Hospital of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07334418 · 859498