Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-31 @ 4:53 PM
Study NCT ID:
NCT03200951
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2017-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000767', 'term': 'Anesthesia, Epidural'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participants and investigator are blinded to group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2017-06-22', 'studyFirstSubmitQcDate': '2017-06-25', 'lastUpdatePostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in the optic nerve sheath diameter(ONSD) between groups', 'timeFrame': '5 minutes before epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography.'}, {'measure': 'The difference in the optic nerve sheath diameter(ONSD) between groups', 'timeFrame': '1 second after epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography.'}, {'measure': 'The difference in the optic nerve sheath diameter(ONSD) between groups', 'timeFrame': '10 minutes after epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography.'}, {'measure': 'The difference in the optic nerve sheath diameter(ONSD) between groups', 'timeFrame': '70 minutes after epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography.'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '5 minutes before epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography'}, {'measure': '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', 'timeFrame': '1 second after epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography'}, {'measure': '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', 'timeFrame': '10 minutes after epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography'}, {'measure': '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', 'timeFrame': '70 minutes after epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '27471390', 'type': 'BACKGROUND', '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.'}, {'pmid': '27659820', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy\n* Body weight ≤ 40 kg\n\nExclusion Criteria:\n\n* Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)\n* Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure\n* Patients with ophthalmic disease or surgery\n* The estimated operation time is less than 70 minutes.\n* All parents of the subject are foreigners or illiterate'}, 'identificationModule': {'nctId': 'NCT03200951', 'briefTitle': 'The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy', 'orgStudyIdInfo': {'id': '4-2017-0341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bolus group', 'interventionNames': ['Drug: Bolus group for epidural block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infusion group', 'interventionNames': ['Drug: Infusion group for epidural block']}], 'interventions': [{'name': 'Bolus group for epidural block', 'type': 'DRUG', 'otherNames': ['ripivacaine'], 'description': 'Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.', 'armGroupLabels': ['Bolus group']}, {'name': 'Infusion group for epidural block', 'type': 'DRUG', 'otherNames': ['ripivacaine'], 'description': 'Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.', 'armGroupLabels': ['Infusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}