Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-28 @ 3:44 AM
Study NCT ID:
NCT04222192
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2020-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Type Ultrasound Guided Epidural Block Methods
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2020-01-04', 'studyFirstSubmitQcDate': '2020-01-07', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of needle routing', 'timeFrame': '20 minutes', 'description': 'number of needle redirects forming successful block'}, {'measure': 'Epidural catheter placement time', 'timeFrame': '20 minutes', 'description': 'time (minutes) until the epidural catheter is inserted'}], 'secondaryOutcomes': [{'measure': 'Epidural igne visibility degree', 'timeFrame': '20 minutes', 'description': '4 = Excellent visibility, 3 = Medium visibility, 2 = Weak visibility 1 = No visibility using a 4-point Likert scale by the practitioner'}, {'measure': 'Difficulty of catheter placement', 'timeFrame': '30 minutes', 'description': 'Assessed by the Practitioner using a 10-point scale, 0: easiest, 10: hardest)'}, {'measure': 'distance measurement of neuraxial structures', 'timeFrame': '30 minutes', 'description': 'Anterior and posterior complex distance measured during epidural administration.\n\nDistance from skin to anterior aspect of ligament flavum (cm)\n\nDistance from skin to posterior dura (cm)'}, {'measure': 'Patient position', 'timeFrame': '20 minutes', 'description': 'Patient position during epidural placement Sitting Lateral'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epidural Anesthesia', 'Ultrasound']}, 'descriptionModule': {'briefSummary': 'The nerve blocks applied with ultrasonography are used for pain and operation after many operations today.\n\nApplications with ultrasonography shorten the processing time, reduce the amount of local anesthetic used and lead to fewer complications.\n\nHowever, the use of ultrasonography is not so common in neuraxial regional anesthesia applications. In the literature, epidural applications accompanied by ultrasonography were applied with different approaches.', 'detailedDescription': 'In this study the investigators will used the two different ultrasound -guided epidural block approach .\n\nParamedian sagittal oblique and Transverse interlaminar. The investigators will used this two technique in epidural catheter placement using the real-time ultrasound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were in the American Society of Anesthesiologists (ASA) I-III class\n* Patients whom need medical epidural anesthesia\n* Patients with consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with a known history of back surgery\n* Bleeding diathesis disorder\n* Allergy to local anesthetics\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT04222192', 'briefTitle': 'Different Type Ultrasound Guided Epidural Block Methods', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Evaluation of Different Type Ultrasound Guided Epidural Block Methods ; Paramedian Sagittal and Transverse Interlaminar View', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2019/12-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Conventional Epidural application', 'description': 'Epidural catheter insertions with conventional (anatomical landmarks use) method', 'interventionNames': ['Other: Epidural block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paramedian sagittal application', 'description': 'Epidural catheter insertions with real time ultrasound guided Paramedian sagittal approach', 'interventionNames': ['Other: Epidural block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transverse Interlaminar application', 'description': 'Epidural catheter insertions with real time ultrasound guided Transverse Interlaminar approach', 'interventionNames': ['Other: Epidural block']}], 'interventions': [{'name': 'Epidural block', 'type': 'OTHER', 'description': 'Epidural catheter insertions', 'armGroupLabels': ['Conventional Epidural application', 'Paramedian sagittal application', 'Transverse Interlaminar application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16110', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Korgün Ökmen, Assoc. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator ,Assoc. PhD. M.D.', 'investigatorFullName': 'Korgün Ökmen', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}