Cesarean Section, Delivery; Trauma
Conditions
Keywords
Cesarean Section, Delivery; Trauma, C-section, PTSD
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.
Interventions
DRUGGeneral anesthetic
standard of care general anesthesia
standard of care intravenous anesthesia
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
1:1
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consent | From hospital admission through day of delivery | Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Randomization | From hospital admission through day of delivery | Percentage of consenting patients who undergo study randomization |
| Quality of postoperative recovery | Postoperative day 0, 1, 2, or 3 | 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. |
| Satifaction with anesthesia | Postoperative day 0, 1, 2, or 3 | 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. |
| Severity and duration of pain | Postoperative day 0, 1, 2, or 3 | 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. |
| Percentage of patients meeting all inclusion criteria out of all screened | From hospital admission through day of delivery | Percentage of patients meeting all inclusion criteria out of all screened |
| Length of stay | Randomization through postoperative day 30 | Post-randomization hospital length of stay via chart review |
| Need for intensive care | Randomization through postoperative day 30 | Need for maternal intensive care via chart review |
| New PTSD (Posttraumatic Stress Disorder) symptoms | Postoperative 6 week | 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. |
| Adverse events | Randomization through postoperative day 30 | Postoperative serious adverse events via chart review |
Contacts
Primary ContactMark Neuman, MD
Outcome results
None listed