Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-01 @ 12:25 PM
Study NCT ID:
NCT03805958
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2019-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-20', 'studyFirstSubmitDate': '2019-01-13', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of needle pass', 'timeFrame': 'intraoperative', 'description': 'Number of needle pass'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anesthesia Morbidity', 'Ultrasonography']}, 'referencesModule': {'references': [{'pmid': '11172514', 'type': 'BACKGROUND', 'citation': 'Grau T, Leipold RW, Conradi R, Martin E, Motsch J. Ultrasound imaging facilitates localization of the epidural space during combined spinal and epidural anesthesia. Reg Anesth Pain Med. 2001 Jan-Feb;26(1):64-7. doi: 10.1053/rapm.2001.19633. No abstract available.'}, {'pmid': '17350519', 'type': 'BACKGROUND', 'citation': 'Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. doi: 10.1016/j.rapm.2006.10.005.'}]}, 'descriptionModule': {'briefSummary': "The investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction between 'Real-time scan' and 'Pre-procedure scan', when we performing spinal/epidural combined anesthesia.", 'detailedDescription': "Traditionally, spinal/epidural combined anesthesia has been performed by palpation of the landmark like Tuffier's line. There are some studies that using ultrasound improves the success rate to regional anesthesia. There are two methods of using ultrasonography, 'Real-time scan' and 'Pre-procedure scan'. Direct comparison of these two methods is not yet studied. So investigators will compare the success rate, the consumed time, the number of needle passing, the depth and angle of the needle, the anesthetic effect, complications, pain and patient's satisfaction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal/Epidural combined anesthesia is required.\n\nExclusion Criteria:\n\n* Skin infection or trauma\n* Abnormal coagulation lab\n* History of spine surgery\n* Pregnancy\n* Abnormal structure of spine'}, 'identificationModule': {'nctId': 'NCT03805958', 'briefTitle': 'Ultrasound-guided Combined Spinal-epidural Anesthesia: Pre-procedure Versus Real-time Scan', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized Comparison of the Ultrasound-guided Combined Spinal-epidural Anesthesia Technique: Pre-procedure Scan Versus Real-time Scan', 'orgStudyIdInfo': {'id': '30-2018-81'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-procedure', 'description': 'Confirmed landmark by ultrasound scan before procedure', 'interventionNames': ['Procedure: prescan ultrasonography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Real time', 'description': 'Confirmed landmark by ultrasound scan during procedure', 'interventionNames': ['Procedure: realtime ultrasonography']}], 'interventions': [{'name': 'realtime ultrasonography', 'type': 'PROCEDURE', 'description': 'Applying realtime ultrasound during the combined anesthesia', 'armGroupLabels': ['Real time']}, {'name': 'prescan ultrasonography', 'type': 'PROCEDURE', 'description': 'Applying realtime ultrasound before the combined anesthesia', 'armGroupLabels': ['Pre-procedure']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tae Kyong Kim, MD, phD', 'role': 'CONTACT', 'email': 'ktkktk@gmail.com', 'phone': '+82-2-870-2519'}], 'overallOfficials': [{'name': 'Tae Kyong Kim, Kim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SMG-SNU Boramae hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Tae Kyong Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}