The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Dec 2021
1 active site
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
December 9, 2021
CompletedStudy Start
First participant enrolled
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedDecember 23, 2022
December 1, 2022
9 months
December 9, 2021
December 22, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
First minute
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
5th minutes
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
15th minutes
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
30th minutes
Study Arms (2)
Group Caudal
ACTIVE COMPARATORCaudal block with 1 ml / kg, % 0.25 bupivacaine
Group Control
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- circumcision,
- inguinal hernia,
- undescended testis,
- hydrocele operation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ataturk University School of Medicine
Erzurum, Yakutiye, 25100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 9, 2021
First Posted
January 31, 2022
Study Start
December 9, 2021
Primary Completion
September 1, 2022
Study Completion
October 30, 2022
Last Updated
December 23, 2022
Record last verified: 2022-12