The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients

Study Overview
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Brief Summary
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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 continuous epidural block on intracranial pressure in pediatric patients undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural analgesia before osteotomy will be divided into bolus group (n=30) and infusion group (n=30). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia. The primary endpoint is the difference in the optic nerve sheath diameter after epidural analgesia measured by optic nerve ultrasonography between groups.

Official Title
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The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients

Conditions
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Osteotomy of Lower Extremity

Intervention / Treatment
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* Procedure: bolus group and infusion group for epidural block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Pediatric patients from 4 to 13 years of age undergoing osteotomy of lower extremity Exclusion Criteria: 1. Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.) 2. Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure 3. Patients with ophthalmic disease or surgery 4. The estimated operation time is less than 180 minutes. 5. All parents of the subject are foreigners or illiterate

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus group<br> | Procedure: bolus group and infusion group for epidural block<br>* Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.<br>|
| Active Comparator: Infusion group<br> | Procedure: bolus group and infusion group for epidural block<br>* Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the optic nerve sheath diameter (ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | Before epidural block | 
| The difference in the optic nerve sheath diameter (ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 30 minutes after epidural block | 
| The difference in the optic nerve sheath diameter (ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 60 minutes after epidural block | 
| The difference in the optic nerve sheath diameter (ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 90 minutes after epidural block | 
| The difference in the optic nerve sheath diameter (ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 120 minutes after epidural block | 
| The difference in the optic nerve sheath diameter (ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 180 minutes after epidural block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | Before epidural block | 
| The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 30 minutes after epidural block | 
| The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 60 minutes after epidural block | 
| The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 90 minutes after epidural block | 
| The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 120 minutes after epidural block | 
| The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 180 minutes after epidural block |