Congenital Heart Disease in Children, Neurologic Complication
Conditions
Keywords
Erector Spinae Plane Blockade, Pediatric Congenital Heart Disease
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.
Interventions
OTHERErector Spinae Plane Block
The 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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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.) |
| 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) |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glutamate | 0-72 Hours | Blood Levels |
| N-Acetylaspartate | 0-72 Hours | Blood Levels |
| Lactate | 0-72 Hours | Blood Levels |
| Choline | 0-72 Hours | Blood Levels |
Contacts
Primary ContactBan Tsui
Backup ContactAaron Deng
Outcome results
None listed