Erector Spinae Plane Block in Congenital Heart Disease Patients

Not Applicable

Not yet recruiting

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Blockade Treatment	Erector Spinae Plane Block	Patients will receive an erector spinae plane blockade prior to their surgery as per standard regional anesthesia technique in addition to the standard of care Volatile Anesthetic Treatment.

Primary Outcome Measures

Name	Time	Method
Neurological and Neurobehavioral Testing - Capute Scale	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)	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	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	12-48 Months Post-Operatively	Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III
Postoperative Opioid Consumption	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)

Secondary Outcome Measures

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