NCT03368833

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

December 15, 2017

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

4.7 years

First QC Date

September 28, 2017

Last Update Submit

February 22, 2023

Conditions

Regional Anesthesia Morbidity

Outcome Measures

Primary Outcomes (2)

  • Change in T wave amplitude

    Change in T wave amplitude on the ECG tracings

    Baseline to 60 mins. post caudal

  • Change in T wave width

    Change in T wave width on the ECG tracings

    Baseline to 60 mins. post caudal

Study Arms (2)

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

Control

Patients who do not receive a caudal block.

Diagnostic Test: Electrocardiogram

Interventions

ElectrocardiogramDIAGNOSTIC_TEST

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

Also known as: ECG, EKG
Caudal blockControl

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients having general surgery at Nationwide Children's Hospital.

You may qualify if:

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

You may not qualify if:

  • Preexisting cardiac comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Senthil Krishna, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

September 28, 2017

First Posted

December 11, 2017

Study Start

December 15, 2017

Primary Completion

September 6, 2022

Study Completion

September 6, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)