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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Drug: Bolus group for epidural block; Drug: Infusion group for epidural block

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bolus group	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.; Other Names: ripivacaine
ACTIVE_COMPARATOR: Infusion group	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.; Other Names: ripivacaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Lin Y, Li Q, Liu J, Yang R, Liu J. Comparison of continuous epidural infusion and programmed intermittent epidural bolus in labor analgesia. Ther Clin Risk Manag. 2016 Jul 14;12:1107-12. doi: 10.2147/TCRM.S106021. eCollection 2016.
• Padayachy LC, Padayachy V, Galal U, Pollock T, Fieggen AG. The relationship between transorbital ultrasound measurement of the optic nerve sheath diameter (ONSD) and invasively measured ICP in children. : Part II: age-related ONSD cut-off values and patency of the anterior fontanelle. Childs Nerv Syst. 2016 Oct;32(10):1779-85. doi: 10.1007/s00381-016-3068-4. Epub 2016 Sep 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 22, 2017
• Primary Completion (ACTUAL): May 31, 2018
• Study Completion (ACTUAL): May 31, 2018

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 25, 2017
• First Posted (ACTUAL): June 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 4-2017-0341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No