The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Neurological and Neurobehavioral Testing - Capute Scale
研究概览
简要总结
Pediatric cardiac patients undergoing surgical anesthesia are at an increased risk of poor neurologic outcome (20-50%). Unattenuated anesthetic exposure and pain contributes to physiologic perturbations that may increase neurologic morbidity. Because of the often-large exposure to anesthetic agents in these cardiac children, at such a young age and the potential modifying anesthetic practice that could lead to improved neurodevelopmental outcomes and surgical recovery is paramount. Regional anesthesia such as thoracic epidurals provide effective analgesia and reduced intraoperative anesthetic needed but carry devastating sequelae neurological risks of epidural hematomas after anticoagulation during cardiopulmonary bypass (CPB). Recently, a newly described erector spinae plane block (ESPB) is superficial to neuraxial or vascular structures, providing opportunity to be placed with less risk for surgery requiring CPB. This block has been described as effective regional anesthesia for adult cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 32 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of at least 32 weeks of gestation, infants and children admitted to The Lucile Packard Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.
- •Admitting diagnosis of cyanotic or non-cyanotic heart disease
排除标准
- •Neonates less than 32 weeks of gestational age
- •Any documented central nervous system malformations.
- •Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support
结局指标
主要结局
Neurological and Neurobehavioral Testing - Capute Scale
时间窗: 12-48 Months Post-Operatively
Evaluate long-term neurological outcomes as per standard of care testing including the and Capute Scales. Scores 86 and higher represent typical neurological development. Scores between 71 and 85 represent borderline delays. Scores 70 or lower indicate significant delays in development.
Length of Stay (LOS)
时间窗: Through hospital stay, an average of 5 days
Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Comparing Changes in EEG Monitoring
时间窗: Pre-operatively and up to 48 hours prior to discharge
Evaluate the changes in EEG waves from measurements performed prior to induction of anesthesia to those collected following the procedure to definitively determine abnormalities in the EEG. The EEG will monitor the Alpha, Beta, Delta, and Theta bandwidths to determine an abnormality.
Neurological and Neurobehavioral Testing - Bayley III
时间窗: 12-48 Months Post-Operatively
Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III
Postoperative Opioid Consumption
时间窗: Through hospital stay, an average of 5 days
Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
次要结局
- Glutamate(0-72 Hours)
- N-Acetylaspartate(0-72 Hours)
- Lactate(0-72 Hours)
- Choline(0-72 Hours)
研究者
Chi-Ho Ban Tsui
Principal Investigator
Stanford University