[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100374635":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":12,"responsibleParty":34,"collaborators":12,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":12,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":12,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":61,"whyStopped":12,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":12},{"fullName":5,"class":6},"Stanford University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nRocuronium or pancuronium will be used for muscle relaxation. Narcotic, fentanyl will be administered at no greater than 2 mcg\u002Fkg\u002Fhr. However, the primary anesthetic during CPB will be isoflurane with no narcotic administered during CPB.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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.",[18],"Other: Erector Spinae Plane Block",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"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.",[14],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Ban Tsui","CONTACT","(650)200-9107","bantsui@stanford.edu",{"name":31,"role":27,"phone":32,"phoneExt":12,"email":33},"Aaron Deng","(408)914-5494","adeng1@stanford.edu",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Chi-Ho Ban Tsui","Principal Investigator","100374635","erector-spinae-plane-block-in-congenital-heart-disease-patients-100374635",false,"NCT04158024","Erector Spinae Plane Block in Congenital Heart Disease Patients","The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients","Inclusion Criteria:\n\n* 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.\n* Admitting diagnosis of cyanotic or non-cyanotic heart disease\n\nExclusion Criteria:\n\n* Neonates less than 32 weeks of gestational age\n* Any documented central nervous system malformations.\n* Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support","ALL","32 Weeks","18 Years",{"count":49,"type":50},150,"ESTIMATED","INTERVENTIONAL",[53],"NA","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.",[56,57],"Congenital Heart Disease in Children","Neurologic Complication",[59,60],"Erector Spinae Plane Blockade","Pediatric Congenital Heart Disease","NOT_YET_RECRUITING","2025-04-30",{"date":64,"type":65},"2025-05-01","ACTUAL",{"date":67,"type":50},"2025-11",{"date":69,"type":50},"2026-11",{"name":5,"class":6}]