Caudal Blockade and Electrocardiographic Changes

NCT ID: NCT03368833

Last Updated: 2023-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2022-09-06

Brief Summary

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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.

Detailed Description

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Conditions

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Regional Anesthesia Morbidity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Caudal block

Patients that receive regional anesthesia in the form of a caudal block prior to surgery as part of their standard of care.

Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.

Control

Patients who do not receive a caudal block.

Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.

Interventions

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Electrocardiogram

12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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ECG EKG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Preexisting cardiac comorbidities
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Senthil G. Krishna

OTHER

Sponsor Role lead

Responsible Party

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Senthil G. Krishna

Attending Anesthesiologist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Senthil Krishna, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB17-00861

Identifier Type: -

Identifier Source: org_study_id

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