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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Drug: Bolus group for epidural block; Drug: Infusion group for epidural block

• Registration Number: NCT03200951
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-25
• Study First Posted: 2017-06-27
• Study Start: 2017-08-22
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy
• Body weight ≤ 40 kg

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus group	Bolus group for epidural block	-
Infusion group	Infusion group for epidural block	-

Primary Outcome Measures

Name	Time	Method
The difference in the optic nerve sheath diameter(ONSD) between groups	70 minutes after epidural block	The optic nerve sheath diameter measured by optic nerve ultrasonography.

Secondary Outcome Measures

Name	Time	Method
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	70 minutes after epidural block	The optic nerve sheath diameter measured by optic nerve ultrasonography

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of