Caudal Blockade and Electrocardiographic Changes

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.

Study Overview

• Status: Terminated
• Conditions: Regional Anesthesia Morbidity
• Intervention / Treatment: Diagnostic test: Electrocardiogram

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Preexisting cardiac comorbidities

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Senthil G. Krishna
• Investigators: Principal Investigator: Senthil Krishna, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB17-00861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No