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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05216211
Other study ID # Optic nerve Caudal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 9, 2021
Est. completion date October 30, 2022

Study information

Verified date December 2022
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 30, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine Hydrochloride
1 ml / kg, % 0.25 bupivacaine

Locations

Country Name City State
Turkey Ataturk University School of Medicine Erzurum Yakutiye

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Optic Nerve Diameter Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes First minute
Primary Optic Nerve Diameter Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes 5th minutes
Primary Optic Nerve Diameter Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes 15th minutes
Primary Optic Nerve Diameter Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes 30th minutes
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