Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT04158024

Erector Spinae Plane Block in 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Congenital Heart Disease in Children Neurologic Complication

Age range

32 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.)

  2. 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)

  3. 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.

  4. 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

  5. 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 outcomes

  1. Choline

    Time frame: 0-72 Hours

    Blood Levels

  2. Glutamate

    Time frame: 0-72 Hours

    Blood Levels

  3. N-Acetylaspartate

    Time frame: 0-72 Hours

    Blood Levels

  4. Lactate

    Time frame: 0-72 Hours

    Blood Levels

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Deng

CONTACT

[email protected]

(408)914-5494

Ban Tsui

CONTACT

[email protected]

(650)200-9107

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2019
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.