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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
600
standard of care general anesthesia
standard of care intravenous anesthesia
Consent
Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment.
Time frame: From hospital admission through day of delivery
Percentage of patients meeting all inclusion criteria out of all screened
Percentage of patients meeting all inclusion criteria out of all screened
Time frame: From hospital admission through day of delivery
Randomization
Percentage of consenting patients who undergo study randomization
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Postoperative day 0, 1, 2, or 3
Adverse events
Postoperative serious adverse events via chart review
Time frame: Randomization through postoperative day 30
Length of stay
Post-randomization hospital length of stay via chart review
Time frame: Randomization through postoperative day 30
Need for intensive care
Need for maternal intensive care via chart review
Time frame: 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.
Time frame: Postoperative 6 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.