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

NCT03911804 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-04-11

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 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.

Conditions

  • Osteotomy of Lower Extremity

Interventions

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2021-03-31
Completion
2021-03-31

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 NCT03911804 on ClinicalTrials.gov