Erector Spinae Plane Block in Congenital Heart Disease Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Erector Spinae Plane Block.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease in Children, Neurologic Complication. Basic parameters: 32 Weeks — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal 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.
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.
Primary outcome measures
- Length of Stay (LOS) [Time frame: Through hospital stay, an average of 5 days]
- Postoperative Opioid Consumption [Time frame: Through hospital stay, an average of 5 days]
- Comparing Changes in EEG Monitoring [Time frame: Pre-operatively and up to 48 hours prior to discharge]
- Neurological and Neurobehavioral Testing - Bayley III [Time frame: 12-48 Months Post-Operatively]
- Neurological and Neurobehavioral Testing - Capute Scale [Time frame: 12-48 Months Post-Operatively]
Secondary outcome measures (4)
- Choline [Time frame: 0-72 Hours]
- Glutamate [Time frame: 0-72 Hours]
- N-Acetylaspartate [Time frame: 0-72 Hours]
- Lactate [Time frame: 0-72 Hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT04158024 · 53993