EAGLET-CS Pilot: Early General Anesthesia to Limit Experiences of Trauma During Cesarean Section-Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Consent
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •We will exclude patients who require induction of general anesthesia prior to umbilical cord clamping and by clinician determination.
研究组 & 干预措施
General anesthesia
Comparator 1: Standard-care general anesthesia: medically induced unconsciousness with breathing tube placement.
干预措施: General anesthetic (Other)
Intravenous sedation
Comparator 2: Time-limited trial of standard care minimal-to-moderate intravenous sedation, with conversion to general anesthesia if pain persists.
干预措施: Intravenous anesthetic (Other)
结局指标
主要结局
Consent
时间窗: From hospital admission through day of delivery
Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment.
Consent
时间窗: From hospital admission through day of delivery
Study consent rate, defined as the number of patients consenting to participation among those approached for enrollment.
次要结局
- Percentage of patients meeting all inclusion criteria out of all screened(From hospital admission through day of delivery)
- Randomization(From hospital admission through day of delivery)
- Quality of postoperative recovery(Postoperative day 0, 1, 2, or 3)
- Satifaction with anesthesia(Postoperative day 0, 1, 2, or 3)
- Percentage of patients meeting all inclusion criteria out of all screened(From hospital admission through day of delivery)
- Randomization(From hospital admission through day of delivery)
- Quality of postoperative recovery(Postoperative day 0, 1, 2, or 3)
- Satifaction with anesthesia(Postoperative day 0, 1, 2, or 3)
- Severity and duration of pain(Postoperative day 0, 1, 2, or 3)
- Adverse events(Randomization through postoperative day 30)
- Length of stay(Randomization through postoperative day 30)
- Need for intensive care(Randomization through postoperative day 30)
- New PTSD (Posttraumatic Stress Disorder) symptoms(Postoperative 6 week)
研究者
Mark Neuman
Principal Investigator
University of Pennsylvania