Erector Spinae Plane Block in Congenital Heart Disease Patients

Overview

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.

Full Title of Study: “The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Length of Stay (LOS)
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 12-48 Months Post-Operatively
    • Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III
  • Neurological and Neurobehavioral Testing – Capute Scale
    • Time Frame: 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.

Secondary Measures

  • Choline
    • Time Frame: 0-72 Hours
    • Blood Levels
  • Glutamate
    • Time Frame: 0-72 Hours
    • Blood Levels
  • N-Acetylaspartate
    • Time Frame: 0-72 Hours
    • Blood Levels
  • Lactate
    • Time Frame: 0-72 Hours
    • Blood Levels

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 32 Weeks

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chi-Ho Ban Tsui, Principal Investigator – Stanford University
  • Overall Contact(s)
    • Ban Tsui, (650)200-9107, bantsui@stanford.edu

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