Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-03-06 @ 2:31 PM
Study NCT ID:
NCT02708459
Status:
COMPLETED
Last Update Posted:
2016-08-30
First Post:
2016-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominus Plane Block in Living Donor Hepatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative morphine (mg) consumption in 1st 48 hours', 'timeFrame': '48 hours postoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Living Donor Hepatectomy']}, 'descriptionModule': {'briefSummary': 'Comparing different drugs used in Transversus abdominus plane analgesia after donor hepatectomy. Patients will be divided into three groups; control group, Bupivecaine group, and Dexmedetomedine group according to the used drug', 'detailedDescription': 'Transversus abdominus plane block for postoperative analgesia after donor hpatectomy surgery using three different drugs control group, Bupivecaine group, and Dexmedetomedine group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all living hepatectomy donors in Mansoura liver transplantation program\n\nExclusion Criteria:\n\n* refusal known sensetivity to used drugs'}, 'identificationModule': {'nctId': 'NCT02708459', 'acronym': 'TAP Donor', 'briefTitle': 'Transversus Abdominus Plane Block in Living Donor Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'orgStudyIdInfo': {'id': 'Abuelella TAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control group where postoperative analgesia will be maintained by Morphine intravenous boluses (2 mg) if Visual analogue scale (VAS) scale more than 4.', 'interventionNames': ['Drug: Intravenous morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupevecaine group', 'description': 'Postoperative analgesia will be maintained by 20 ml Bupevecaine (0.25%) boluses in surgically inserted TAP catheter each 8 hours for 48 hours with rescue analgesia intravenous morphine (2mg) if VAS more than 4', 'interventionNames': ['Device: surgically inserted Transversus abdominus plane catheter', 'Drug: Intravenous morphine', 'Drug: Bupevecaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dex group', 'description': 'catheter will surgically inserted in Transversus abdominus plane (TAP) plane before wound closure Postoperative analgesia will be maintained by Dexmedetomedine 0.4 mg/kg plus Bupevecaine 0.25 20 ml boluses each 8 hours for 48 hours in surgically inserted TAP catheter with rescue analgesia intravenous morphine (2mg) if VAS more 4', 'interventionNames': ['Device: surgically inserted Transversus abdominus plane catheter', 'Drug: Intravenous morphine', 'Drug: Bupevecaine', 'Drug: Dexmedetomedine']}], 'interventions': [{'name': 'surgically inserted Transversus abdominus plane catheter', 'type': 'DEVICE', 'description': 'at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle', 'armGroupLabels': ['Bupevecaine group', 'Dex group']}, {'name': 'Intravenous morphine', 'type': 'DRUG', 'description': 'Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3', 'armGroupLabels': ['Bupevecaine group', 'Control', 'Dex group']}, {'name': 'Bupevecaine', 'type': 'DRUG', 'armGroupLabels': ['Bupevecaine group', 'Dex group']}, {'name': 'Dexmedetomedine', 'type': 'DRUG', 'armGroupLabels': ['Dex group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62215', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'city': 'Al Mansurah', 'state': 'Dkahleya', 'country': 'Egypt', 'facility': 'Mansoura university', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AlRefaey Kandeel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'AlRefaey Kandeel', 'investigatorAffiliation': 'Mansoura University'}}}}