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Erector Spinae Plane Block in Congenital Heart Disease Patients

Primary Purpose

Congenital Heart Disease in Children, Neurologic Complication

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease in Children focused on measuring Erector Spinae Plane Blockade, Pediatric Congenital Heart Disease

Eligibility Criteria

32 Weeks - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Volatile Anesthetic Control

    Erector Spinae Plane Blockade Treatment

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.)
    Postoperative Opioid Consumption
    Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
    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.
    Neurological and Neurobehavioral Testing - Bayley III
    Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III
    Neurological and Neurobehavioral Testing - Capute Scale
    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 Outcome Measures

    Choline
    Blood Levels
    Glutamate
    Blood Levels
    N-Acetylaspartate
    Blood Levels
    Lactate
    Blood Levels

    Full Information

    First Posted
    November 6, 2019
    Last Updated
    April 17, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04158024
    Brief Title
    Erector Spinae Plane Block in Congenital Heart Disease Patients
    Official Title
    The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Disease in Children, Neurologic Complication
    Keywords
    Erector Spinae Plane Blockade, Pediatric Congenital Heart Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Volatile Anesthetic Control
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Erector Spinae Plane Blockade Treatment
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Erector Spinae Plane Block
    Intervention Description
    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 Measure Information:
    Title
    Length of Stay (LOS)
    Description
    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
    Title
    Postoperative Opioid Consumption
    Description
    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
    Title
    Comparing Changes in EEG Monitoring
    Description
    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
    Title
    Neurological and Neurobehavioral Testing - Bayley III
    Description
    Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III
    Time Frame
    12-48 Months Post-Operatively
    Title
    Neurological and Neurobehavioral Testing - Capute Scale
    Description
    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.
    Time Frame
    12-48 Months Post-Operatively
    Secondary Outcome Measure Information:
    Title
    Choline
    Description
    Blood Levels
    Time Frame
    0-72 Hours
    Title
    Glutamate
    Description
    Blood Levels
    Time Frame
    0-72 Hours
    Title
    N-Acetylaspartate
    Description
    Blood Levels
    Time Frame
    0-72 Hours
    Title
    Lactate
    Description
    Blood Levels
    Time Frame
    0-72 Hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Weeks
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ban Tsui
    Phone
    (650)200-9107
    Email
    bantsui@stanford.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aaron Deng
    Phone
    (408)914-5494
    Email
    adeng1@stanford.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Erector Spinae Plane Block in Congenital Heart Disease Patients

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