Erector Spinae Plane Block in Congenital Heart Disease Patients

Congenital Heart Disease in Children Clinical Trial

Official title:

The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04158024
• Other study ID #: 53993
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Ban Tsui
• Phone: (650)200-9107
• Email: bantsui[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks to 18 Years

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

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Neurologic Complication

Intervention

Other:
• Erector 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	Through hospital stay, an average of 5 days
Primary	Postoperative Opioid Consumption	Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)	Through hospital stay, an average of 5 days
Primary	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.	Pre-operatively and up to 48 hours prior to discharge
Primary	Neurological and Neurobehavioral Testing - Bayley III	Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III	12-48 Months Post-Operatively
Primary	Neurological and Neurobehavioral Testing - Capute Scale	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.	12-48 Months Post-Operatively
Secondary	Choline	Blood Levels	0-72 Hours
Secondary	Glutamate	Blood Levels	0-72 Hours
Secondary	N-Acetylaspartate	Blood Levels	0-72 Hours
Secondary	Lactate	Blood Levels	0-72 Hours