Clinical trial NCT03200951: The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy
Official title: The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 40
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 of 0.15% ripivacaine for epidudral block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: The difference in the optic nerve sheath diameter(ONSD) between groups
timeFrame: 5 minutes before epidural block
measure: The difference in the optic nerve sheath diameter(ONSD) between groups
timeFrame: 1 second after epidural block
measure: The difference in the optic nerve sheath diameter(ONSD) between groups
timeFrame: 10 minutes after epidural block
measure: The difference in the optic nerve sheath diameter(ONSD) between groups
timeFrame: 70 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: 5 minutes 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: 1 second 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: 10 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: 70 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.