Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-06 @ 2:11 AM
Study NCT ID:
NCT03911804
Status:
UNKNOWN
Last Update Posted:
2019-04-11
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants, care providers and investigators are blinded to group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in the optic nerve sheath diameter (ONSD) between groups', 'timeFrame': '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': '30 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': '60 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': '90 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': '120 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': '180 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': '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': '30 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': '60 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': '90 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': '120 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': '180 minutes after epidural block', 'description': 'The optic nerve sheath diameter measured by optic nerve ultrasonography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteotomy of Lower Extremity']}, '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 continuous epidural block on intracranial pressure in pediatric patients undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural analgesia before osteotomy will be divided into bolus group (n=30) and infusion group (n=30). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia. The primary endpoint is the difference in the optic nerve sheath diameter after epidural analgesia 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* 1\\. Pediatric patients from 4 to 13 years of age undergoing osteotomy of lower extremity\n\nExclusion Criteria:\n\n* 1\\. Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)\n* 2\\. Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure\n* 3\\. Patients with ophthalmic disease or surgery\n* 4\\. The estimated operation time is less than 180 minutes.\n* 5\\. All parents of the subject are foreigners or illiterate'}, 'identificationModule': {'nctId': 'NCT03911804', 'briefTitle': 'The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients', 'orgStudyIdInfo': {'id': '1-2019-0004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bolus group', 'interventionNames': ['Procedure: bolus group and infusion group for epidural block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infusion group', 'interventionNames': ['Procedure: bolus group and infusion group for epidural block']}], 'interventions': [{'name': 'bolus group and infusion group for epidural block', 'type': 'PROCEDURE', 'description': 'Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.', 'armGroupLabels': ['Bolus group', 'Infusion group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Yong Seon Choi, MD, Ph.D', 'role': 'CONTACT', 'email': 'yschoi@yush.ac', 'phone': '+82-2-2228-2412'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}