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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-22

Study Completion Date

2018-05-31

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.

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Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Participants and investigator are blinded to group assignment.

Study Groups

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Bolus group

Group Type EXPERIMENTAL

Bolus group for epidural block

Intervention Type DRUG

Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.

Infusion group

Group Type ACTIVE_COMPARATOR

Infusion group for epidural block

Intervention Type DRUG

Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.

Interventions

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Bolus group for epidural block

Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.

Intervention Type DRUG

Infusion group for epidural block

Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.

Intervention Type DRUG

Other Intervention Names

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ripivacaine ripivacaine

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No