Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-01-10 @ 11:26 AM
Study NCT ID:
NCT02937792
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2016-10-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-18', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vital signs', 'timeFrame': '45 minutes', 'description': 'blood pressure, heart rate'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': '45 minutes', 'description': 'nausea, vomiting and total spinal'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'To test the safety of high dose spinal in elective CS after prolonged sitting position.', 'detailedDescription': 'This is a prospective double-blind randomized study, designed to include cases in two groups (using epical program for sample size calculation), one study groups and one control group (parallel). Each group should have at least 30 female patients scheduled for elective caesarean section with a total of 60 cases.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance\n\nExclusion Criteria:\n\n* Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal'}, 'identificationModule': {'nctId': 'NCT02937792', 'briefTitle': 'Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section', 'orgStudyIdInfo': {'id': '3 ml bupivacaine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'CONTROL', 'description': 'one with intrathecal 12.5 mg bupivacaine'}, {'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'one group with intrathecal 15 mg bupivacaine', 'interventionNames': ['Drug: intrathecal 15 mg bupivacaine']}], 'interventions': [{'name': 'intrathecal 15 mg bupivacaine', 'type': 'DRUG', 'otherNames': ['large dose spinal'], 'description': 'spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section', 'armGroupLabels': ['experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Cairo', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'HASSAN M ALI, LECTURER', 'role': 'CONTACT', 'email': 'hassan364@hotmail.com', 'phone': '+201001733687'}], 'facility': 'Cairo University'}], 'centralContacts': [{'name': 'Hassan Ali, lecturer', 'role': 'CONTACT', 'email': 'hassan364@hotmail.com', 'phone': '1001733687'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in anesthesia department Cairo university', 'investigatorFullName': 'Hassan Mohamed Ali', 'investigatorAffiliation': 'Cairo University'}}}}