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

NCT03200951 | Completed

• 1 other identifier: 4-2017-0341
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (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

  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

  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

  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

  70 minutes after epidural block

Study Arms (2)

Bolus group

EXPERIMENTAL

Drug: Bolus group for epidural block

Infusion group

ACTIVE COMPARATOR

Drug: Infusion group for epidural block

Interventions

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.

Also known as: ripivacaine

Bolus group

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.

Also known as: ripivacaine

Infusion group

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy
• Body weight ≤ 40 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

Related Publications (2)

• 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.

  PMID: 27471390 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.

  PMID: 27659820 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigator are blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 27, 2017
• Study Start: August 22, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)