About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Erector Spinae Plane Block
Other interventionThe ESPB is a fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.
Treatment groups
Trial outcomes
Primary outcomes
Length of Stay (LOS)
Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Postoperative Opioid Consumption
Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
Comparing Changes in EEG Monitoring
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
Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III
Secondary outcomes
Choline
Blood Levels
Glutamate
Blood Levels
N-Acetylaspartate
Blood Levels
Lactate
Blood Levels
Locations
Sponsors and contacts
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