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

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.

Study Overview

• Status: Unknown
• Conditions: Osteotomy of Lower Extremity
• Intervention / Treatment: Procedure: bolus group and infusion group for epidural block

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
    • Contact: Yong Seon Choi, MD, Ph.D; Phone Number: +82-2-2228-2412; Email: yschoi@yush.ac

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:

• 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.)
• 2. Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
• 3. Patients with ophthalmic disease or surgery
• 4. The estimated operation time is less than 180 minutes.
• 5. 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 Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bolus group	Procedure: bolus group and infusion group for epidural block; 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.
Active Comparator: Infusion group	Procedure: bolus group and infusion group for epidural block; 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.

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	Before epidural block
The difference in the optic nerve sheath diameter (ONSD) between groups	The optic nerve sheath diameter measured by optic nerve ultrasonography	30 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	60 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	90 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	120 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	180 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	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	30 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	60 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	90 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	120 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	180 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 (Anticipated): April 1, 2019
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1-2019-0004

Drug and device information, study documents

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