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NCT Number: NCT03200951

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

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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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ripivacaine

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.

Other names: ripivacaine

Primary outcomes

  1. The difference in the optic nerve sheath diameter(ONSD) between groups

    Time frame: 5 minutes before epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography.

  2. The difference in the optic nerve sheath diameter(ONSD) between groups

    Time frame: 1 second after epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography.

  3. The difference in the optic nerve sheath diameter(ONSD) between groups

    Time frame: 10 minutes after epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography.

  4. The difference in the optic nerve sheath diameter(ONSD) between groups

    Time frame: 70 minutes after epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography.

Secondary outcomes

  1. 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

    Time frame: 5 minutes before epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography

  2. 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

    Time frame: 1 second after epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography

  3. 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

    Time frame: 10 minutes after epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography

  4. 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

    Time frame: 70 minutes after epidural block

    The optic nerve sheath diameter measured by optic nerve ultrasonography

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 27, 2017
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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