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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

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Yonsei University

Status

Unknown

Conditions

Osteotomy of Lower Extremity

Treatments

Procedure: bolus group and infusion group for epidural block

Study type

Interventional

Funder types

Other

Identifiers

NCT03911804
1-2019-0004

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

4 to 13 years old

Volunteers

No Healthy Volunteers

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.)
    1. Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
    1. Patients with ophthalmic disease or surgery
    1. The estimated operation time is less than 180 minutes.
    1. All parents of the subject are foreigners or illiterate

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

Bolus group
Experimental group
Treatment:
Procedure: bolus group and infusion group for epidural block
Infusion group
Active Comparator group
Treatment:
Procedure: bolus group and infusion group for epidural block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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