Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:35 PM
Study NCT ID:
NCT04921761
Status:
WITHDRAWN
Last Update Posted:
2021-11-22
First Post:
2021-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt']}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'There is a duplicate study registered. The trial registration and later updates will be in NCT04933500. That is the record that will be updated.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-13', 'studyFirstSubmitDate': '2021-06-05', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of onset of anesthesia to T10', 'timeFrame': 'During surgery'}, {'measure': 'Time for complete motor block', 'timeFrame': 'During surgery'}, {'measure': 'Time for first rescue analgesia will be required during surgery', 'timeFrame': 'During surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dural Puncture Epidural Technique']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge (25- 55) years. Height (150 -170) cm.\n\nExclusion Criteria:\n\nPatient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.'}, 'identificationModule': {'nctId': 'NCT04921761', 'briefTitle': 'Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'National Research Centre, Egypt'}, 'officialTitle': 'Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries', 'orgStudyIdInfo': {'id': 'Dural Puncture'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A', 'description': 'Women who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural', 'interventionNames': ['Procedure: Conventional epidural']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Women who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural', 'interventionNames': ['Procedure: Dural puncture epidural']}], 'interventions': [{'name': 'Conventional epidural', 'type': 'PROCEDURE', 'description': 'In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.', 'armGroupLabels': ['Group A']}, {'name': 'Dural puncture epidural', 'type': 'PROCEDURE', 'description': 'In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.', 'armGroupLabels': ['Group B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre, Egypt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}