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

Not Applicable

• Conditions: Osteotomy of Lower Extremity
• Interventions: Procedure: bolus group and infusion group for epidural block

• Registration Number: NCT03911804
• 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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-04
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Last Update Submitted: 2019-04-09
• Study First Posted: 2019-04-11
• Last Update Posted: 2019-04-11
• Primary Completion: 2021-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bolus group	bolus group and infusion group for epidural block	-
Infusion group	bolus group and infusion group for epidural block	-

Primary Outcome Measures

Name	Time	Method
The difference in the optic nerve sheath diameter (ONSD) between groups	180 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	180 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