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

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Bolus group for epidural block

Infusion group for epidural block

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bolus group

Infusion group

Arm Description

Outcomes

Primary Outcome Measures

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

The optic nerve sheath diameter measured by optic nerve ultrasonography.

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

The optic nerve sheath diameter measured by optic nerve ultrasonography.

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

The optic nerve sheath diameter measured by optic nerve ultrasonography.

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

The optic nerve sheath diameter measured by optic nerve ultrasonography.

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT03200951

First Posted

June 22, 2017

Last Updated

October 25, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03200951

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 22, 2017 (Actual)

Primary Completion Date

May 31, 2018 (Actual)

Study Completion Date

May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigator

Masking Description

Participants and investigator are blinded to group assignment.

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bolus group

Arm Type

Experimental

Arm Title

Infusion group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Bolus group for epidural block

Other Intervention Name(s)

ripivacaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Infusion group for epidural block

Other Intervention Name(s)

ripivacaine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography.

Time Frame

5 minutes before epidural block

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography.

Time Frame

1 second after epidural block

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography.

Time Frame

10 minutes after epidural block

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography.

Time Frame

70 minutes after epidural block

Secondary Outcome Measure Information:

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography

Time Frame

5 minutes before epidural block

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography

Time Frame

1 second after epidural block

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography

Time Frame

10 minutes after epidural block

Title

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

Description

The optic nerve sheath diameter measured by optic nerve ultrasonography

Time Frame

70 minutes after epidural block

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27471390

Citation

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.

Results Reference

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PubMed Identifier

27659820

Citation

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.

Results Reference

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

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