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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus group | Experimental |
| |
| Infusion group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus group for epidural block | Drug | Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. |
|
| 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. | 5 minutes before epidural block |
| The difference in the optic nerve sheath diameter(ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography. | 1 second after epidural block |
| The difference in the optic nerve sheath diameter(ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography. | 10 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. | 70 minutes after epidural block |
| 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 | 5 minutes 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27471390 | Background | 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. | |
| 27659820 | Background | 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. |
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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.
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Participants and investigator are blinded to group assignment.
| Infusion group for epidural block | Drug | Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. |
|
|
The optic nerve sheath diameter measured by optic nerve ultrasonography |
| 1 second 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 | 10 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 | 70 minutes after epidural block |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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