Erector Spinae Plane Block in Congenital Heart Disease Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-18
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erector Spinae Plane Block

    Other intervention

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Volatile Anesthetic ControlNo intervention 0 interventions
Group B: Erector Spinae Plane Blockade TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.)

Time frame
Through hospital stay, an average of 5 days
2

Postoperative Opioid Consumption

Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)

Time frame
Through hospital stay, an average of 5 days
3

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.

Time frame
Pre-operatively and up to 48 hours prior to discharge
4

Neurological and Neurobehavioral Testing - Bayley III

Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III

Time frame
12-48 Months Post-Operatively

Secondary outcomes

1

Choline

Blood Levels

Time frame
0-72 Hours
2

Glutamate

Blood Levels

Time frame
0-72 Hours
3

N-Acetylaspartate

Blood Levels

Time frame
0-72 Hours
4

Lactate

Blood Levels

Time frame
0-72 Hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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