Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
We will exclude patients who require induction of general anesthesia prior to umbilical cord clamping and by clinician determination.
Trial design
Design model
Parallel
Treatments tested in this trial
General anesthetic
Other interventionstandard of care general anesthesia
Intravenous anesthetic
Other interventionstandard of care intravenous anesthesia
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: General anesthesiaActive comparator 1 intervention
Group B: Intravenous sedationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 deliverySecondary outcomes
1
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 delivery2
Randomization
Percentage of consenting patients who undergo study randomization
Time frame
From hospital admission through day of delivery3
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 34
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 3Sponsors and contacts
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Source ClinicalTrials.gov