Clinical trial NCT03911804: The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients
Official title: The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteotomy of Lower Extremity
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 given 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The difference in the optic nerve sheath diameter (ONSD) between groups
timeFrame: Before epidural block
measure: The difference in the optic nerve sheath diameter (ONSD) between groups
timeFrame: 30 minutes after epidural block
measure: The difference in the optic nerve sheath diameter (ONSD) between groups
timeFrame: 60 minutes after epidural block
measure: The difference in the optic nerve sheath diameter (ONSD) between groups
timeFrame: 90 minutes after epidural block
measure: The difference in the optic nerve sheath diameter (ONSD) between groups
timeFrame: 120 minutes after epidural block
measure: The difference in the optic nerve sheath diameter (ONSD) between groups
timeFrame: 180 minutes after epidural block
Secondary outcomes:
measure: 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
timeFrame: Before epidural block
measure: 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
timeFrame: 30 minutes after epidural block
measure: 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
timeFrame: 60 minutes after epidural block
measure: 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
timeFrame: 90 minutes after epidural block
measure: 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
timeFrame: 120 minutes after epidural block
measure: 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
timeFrame: 180 minutes after epidural block
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Study officials:
References:
citation: 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.
citation: 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.