The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03200951

Enrollment

Registered

2017-06-27

Start date

2017-08-22

Completion date

2018-05-31

Last updated

2018-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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.

Interventions

DRUGBolus group for epidural block

Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.

DRUGInfusion group for epidural block

Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Participants and investigator are blinded to group assignment.

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.

Eligibility

Sex/Gender

ALL

Age

4 Years to 13 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The difference in the optic nerve sheath diameter(ONSD) between groups	5 minutes 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	5 minutes before epidural block	The optic nerve sheath diameter measured by optic nerve ultrasonography

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026