Erector Spinae Plane Block in Congenital Heart Disease Patients

Stanford University

Status: Not yet enrolling

Conditions: Neurologic Complication; Congenital Heart Disease in Children

Treatments: Other: Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT04158024

53993

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 32 weeks to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups

Volatile Anesthetic Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Erector Spinae Plane Block