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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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ClinicalTrials.gov Identifier: NCT03200951
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Bolus group for epidural block Drug: Infusion group for epidural block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel 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.
Masking: Double (Participant, Investigator)
Masking Description: Participants and investigator are blinded to group assignment.
Primary Purpose: Treatment
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
Actual Study Start Date : August 22, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

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Arm Intervention/treatment
Experimental: Bolus group Drug: Bolus 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.
Other Name: ripivacaine

Active Comparator: Infusion group Drug: Infusion group for epidural block
Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
Other Name: ripivacaine




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   4 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200951


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03200951    
Other Study ID Numbers: 4-2017-0341
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases