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Erector Spinae Plane Block in Congenital Heart Disease Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158024
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease in Children Neurologic Complication Other: Erector Spinae Plane Block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
No Intervention: Volatile Anesthetic Control

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.

Experimental: Erector Spinae Plane Blockade Treatment
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.
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 :
  1. Length of Stay (LOS) [ Time Frame: Through hospital stay, an average of 5 days ]
    Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)

  2. Postoperative Opioid Consumption [ Time Frame: Through hospital stay, an average of 5 days ]
    Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)

  3. Comparing Changes in EEG Monitoring [ Time Frame: Pre-operatively and up to 48 hours prior to discharge ]
    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.

  4. Neurological and Neurobehavioral Testing - Bayley III [ Time Frame: 12-48 Months Post-Operatively ]
    Evaluate long-term neurological outcomes as per standard of care testing including the Bayley Exam III

  5. Neurological and Neurobehavioral Testing - Capute Scale [ Time Frame: 12-48 Months Post-Operatively ]
    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 :
  1. Choline [ Time Frame: 0-72 Hours ]
    Blood Levels

  2. Glutamate [ Time Frame: 0-72 Hours ]
    Blood Levels

  3. N-Acetylaspartate [ Time Frame: 0-72 Hours ]
    Blood Levels

  4. Lactate [ Time Frame: 0-72 Hours ]
    Blood Levels



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Ages Eligible for Study:   32 Weeks to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158024


Contacts
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Contact: Ban Tsui (650)200-9107 bantsui@stanford.edu
Contact: Aaron Deng (408)914-5494 adeng1@stanford.edu

Sponsors and Collaborators
Stanford University
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Responsible Party: Chi-Ho Ban Tsui, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT04158024    
Other Study ID Numbers: 53993
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi-Ho Ban Tsui, Stanford University:
Erector Spinae Plane Blockade
Pediatric Congenital Heart Disease
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities