Back to resultsThe Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
Primary Purpose
Postoperative Pain, Intracranial Hypertension
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Sponsored by
About this trial
This is an interventional diagnostic trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Ataturk University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Group Caudal
Group Control
Arm Description
Caudal block with 1 ml / kg, % 0.25 bupivacaine
No intervention
Outcomes
Primary Outcome Measures
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Optic Nerve Diameter
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05216211
Brief Title
The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
Official Title
The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Intracranial Hypertension
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Caudal
Arm Type
Active Comparator
Arm Description
Caudal block with 1 ml / kg, % 0.25 bupivacaine
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
1 ml / kg, % 0.25 bupivacaine
Primary Outcome Measure Information:
Title
Optic Nerve Diameter
Description
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Time Frame
First minute
Title
Optic Nerve Diameter
Description
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Time Frame
5th minutes
Title
Optic Nerve Diameter
Description
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Time Frame
15th minutes
Title
Optic Nerve Diameter
Description
Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes
Time Frame
30th minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ataturk University School of Medicine
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
25100
Country
Turkey
12. IPD Sharing Statement
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The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients
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