Erector Spinae Plane Block in Congenital Heart Disease Patients

NCT04158024 | Not Yet Recruiting

• 1 other identifier: 53993
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Heart Disease in Children; Neurologic Complication

Keywords

Erector Spinae Plane Blockade; Pediatric Congenital Heart Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Choline

  0-72 Hours

• Glutamate

  0-72 Hours

• N-Acetylaspartate

  0-72 Hours

• Lactate

  0-72 Hours

Study Arms (2)

Volatile Anesthetic Control

NO INTERVENTION

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.

Erector Spinae Plane Blockade Treatment

EXPERIMENTAL

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

Interventions

Erector Spinae Plane Block OTHER

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.

Erector Spinae Plane Blockade Treatment

Eligibility Criteria

• Age: 32 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Central Study Contacts

Ban Tsui

CONTACT

(650)200-9107; bantsui@stanford.edu

Aaron Deng

CONTACT

(408)914-5494; adeng1@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share