Erector Spinae Plane Block in Congenital Heart Disease Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease in Children; Neurologic Complication
• Intervention / Treatment: Other: Erector Spinae Plane Block

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ban Tsui; Phone Number: (650)200-9107; Email: bantsui@stanford.edu
• Study Contact Backup: Name: Aaron Deng; Phone Number: (408)914-5494; Email: adeng1@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Volatile Anesthetic Control; In volatile anesthetic technique, maintenance of anesthesia will be standardized to the volatile anesthetic isoflurane. Isoflurane will be delivered at 1.5-2.0%% as required for anesthetic management. Rocuronium or pancuronium will be used for muscle relaxation. Narcotic, fentanyl will be administered at no greater than 2 mcg/kg/hr. However, the primary anesthetic during CPB will be isoflurane with no narcotic administered during CPB.
Experimental: Erector Spinae Plane Blockade Treatment; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Choline	Blood Levels	0-72 Hours
Glutamate	Blood Levels	0-72 Hours
N-Acetylaspartate	Blood Levels	0-72 Hours
Lactate	Blood Levels	0-72 Hours

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Erector Spinae Plane Blockade; Pediatric Congenital Heart Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 53993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No