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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 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.
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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 and infusion group for epidural block | Procedure | 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. |
| 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 | Before epidural block |
| The difference in the optic nerve sheath diameter (ONSD) between groups | The optic nerve sheath diameter measured by optic nerve ultrasonography | 30 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 | 60 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 | 90 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 | 120 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 | 180 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 | 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 | Recruiting | 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/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.
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Participants, care providers and investigators are blinded to group assignment.
|
The optic nerve sheath diameter measured by optic nerve ultrasonography |
| 30 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 | 60 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 | 90 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 | 120 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 | 180 minutes after epidural block |
| ID | Term |
|---|---|
| D000767 | Anesthesia, Epidural |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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