Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block

Study Overview
=================
Brief Summary
-----------------
The recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. It was supposed to be associated with increased intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.

Conditions
-----------------
Orchiopexy, Inguinal Hernioplasty, Hydrocelectomy, Diverticulectomy, Fistula Repair, Penoplasty

Intervention / Treatment
-----------------
* Drug: 1.0 ml/kg of 0.15% ropivacaine
* Drug: 1.5 ml/kg of 0.15% ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients weighing less than 16 kg who receive caudal block before urologic surgery Exclusion Criteria: Subjects are ineligible if they have contraindication for caudal block such as infection, coagulopathy, anomaly, or past medical history related to increased intracranial pressure ophthalmic disease expected operation time is less than 30 minutes both parents are unable to communicate or speak Korean.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 4 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low dose group<br>Patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. | Drug: 1.0 ml/kg of 0.15% ropivacaine<br>* Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.<br>|
| Active Comparator: high dose group<br>Patients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. | Drug: 1.5 ml/kg of 0.15% ropivacaine<br>* Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the optic nerve sheath diameter between groups |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The variation in the optic nerve sheath diameter before and after caudal block |  | 30 minutes | 
| the difference in the variation of the optic nerve sheath diameter between groups |  | 30 minutes |