The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients

December 22, 2022 updated by: Ahmet Murat Yayik, Ataturk University
Caudal epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement has high diagnostic accuracy for detecting increased intracranial pressure in children. The aim of the study is to investigate the effect of the caudal block on optic nerve sheath diameter in pediatric patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25100
        • Ataturk University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • circumcision,
  • inguinal hernia,
  • undescended testis,
  • hydrocele operation

Exclusion Criteria:

  • neurological or spinal anomaly,
  • coagulopathy
  • allergy to local anesthetics,
  • local infection in the area to be intervention,
  • with increased intracranial pressure
  • children with any ophthalmic pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group Control
No intervention
Active Comparator: Group Caudal
Caudal block with 1 ml / kg, % 0.25 bupivacaine
Drug: Bupivacaine Hydrochloride
1 ml / kg, % 0.25 bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic Nerve Diameter
Time Frame: First minute
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
First minute
Optic Nerve Diameter
Time Frame: 5th minutes
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
5th minutes
Optic Nerve Diameter
Time Frame: 15th minutes
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
15th minutes
Optic Nerve Diameter
Time Frame: 30th minutes
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
30th minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

January 18, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Estimate)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 22, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Optic nerve Caudal

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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