Erector Spinae Plane Block in Congenital Heart Disease Patients
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|ClinicalTrials.gov Identifier: NCT04158024|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease in Children Neurologic Complication||Other: Erector Spinae Plane Block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- 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.)
- 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)
- 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.
- 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
- 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.
- Choline [ Time Frame: 0-72 Hours ]Blood Levels
- Glutamate [ Time Frame: 0-72 Hours ]Blood Levels
- N-Acetylaspartate [ Time Frame: 0-72 Hours ]Blood Levels
- Lactate [ Time Frame: 0-72 Hours ]Blood Levels
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158024
|Contact: Ban Tsui||(650)firstname.lastname@example.org|
|Contact: Aaron Deng||(408)email@example.com|