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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Active Comparator | Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement. |
|
| Intravenous sedation | Active Comparator | Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthetic | Other | standard of care general anesthesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Consent | Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment. | From hospital admission through day of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients meeting all inclusion criteria out of all screened | Percentage of patients meeting all inclusion criteria out of all screened | From hospital admission through day of delivery |
| Randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Neuman, MD | Contact | 215-746-7468 | eagletadmin@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018681 | Anesthetics, General |
| D018686 | Anesthetics, Intravenous |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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1:1
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| Intravenous anesthetic |
| Other |
standard of care intravenous anesthesia |
|
Percentage of consenting patients who undergo study randomization
| 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. | 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. | 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. | Postoperative day 0, 1, 2, or 3 |
| Adverse events | Postoperative serious adverse events via chart review | Randomization through postoperative day 30 |
| Length of stay | Post-randomization hospital length of stay via chart review | Randomization through postoperative day 30 |
| Need for intensive care | Need for maternal intensive care via chart review | 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. | Postoperative 6 week |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |