Osteotomy of Lower Extremity
Conditions
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.
Interventions
PROCEDUREbolus 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
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants, care providers and investigators are blinded to group assignment.
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference in the optic nerve sheath diameter (ONSD) between groups | Before epidural block | The optic nerve sheath diameter measured by optic nerve ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Before epidural block | The optic nerve sheath diameter measured by optic nerve ultrasonography |
Countries
South Korea
Outcome results
None listed