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Caudal Blockade and Electrocardiographic Changes

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ClinicalTrials.gov Identifier: NCT03368833
Recruitment Status : Enrolling by invitation
First Posted : December 11, 2017
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Senthil G. Krishna, Nationwide Children's Hospital

Study Description
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Brief Summary:
Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. This study will look at the delayed effects of a caudal epidural block on the electrical activity of the patient's myocardium by trying to characterize the incidence of ECG changes within 60 minutes after the caudal dose is given.

Condition or disease Intervention/treatment
Regional Anesthesia Morbidity Diagnostic Test: Electrocardiogram

Study Design
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Caudal Blockade and Electrocardiographic Changes
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Caudal block
Patients that receive regional anesthesia in the form of a caudal block prior to surgery as part of their standard of care.
 Diagnostic Test: Electrocardiogram
12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.
Other Names:
  • ECG
  • EKG
Control
Patients who do not receive a caudal block.
 Diagnostic Test: Electrocardiogram
12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.
Other Names:
  • ECG
  • EKG


Outcome Measures
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Primary Outcome Measures :
  1. Change in T wave amplitude [ Time Frame: Baseline to 60 mins. post caudal ]
    Change in T wave amplitude on the ECG tracings

  2. Change in T wave width [ Time Frame: Baseline to 60 mins. post caudal ]
    Change in T wave width on the ECG tracings


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients having general surgery at Nationwide Children's Hospital.
Criteria

Inclusion Criteria:

  • ASA grade 1 or 2
  • Receiving general anesthesia with a caudal block

Exclusion Criteria:

  • Preexisting cardiac comorbidities
Contacts and Locations
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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): NCT03368833


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Senthil G. Krishna
Investigators
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Principal Investigator: Senthil Krishna, MD Nationwide Children's Hospital
More Information
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Responsible Party: Senthil G. Krishna, Attending Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03368833    
Other Study ID Numbers: IRB17-00861
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
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