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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

NCT03200951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-10-29

No results posted yet for this study

Summary

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.

Conditions

  • Cerebral Palsy

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200951 on ClinicalTrials.gov