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

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 epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve sheath diameter after epidural block measured by optic nerve ultrasonography between groups.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Drug: Bolus group for epidural block
* Drug: Infusion group for epidural block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy Body weight ≤ 40 kg Exclusion Criteria: Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.) Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure Patients with ophthalmic disease or surgery The estimated operation time is less than 70 minutes. 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 of 0.15% ripivacaine for epidudral block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus group<br> | Drug: Bolus group for epidural block<br>* Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.<br>* Other names: ripivacaine;|
| Active Comparator: Infusion group<br> | Drug: Infusion group for epidural block<br>* Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.<br>* Other names: ripivacaine;|

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. | 5 minutes before epidural block | 
| The difference in the optic nerve sheath diameter(ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography. | 1 second after epidural block | 
| The difference in the optic nerve sheath diameter(ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography. | 10 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. | 70 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 | 5 minutes 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 | 1 second 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 | 10 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 | 70 minutes after epidural block |