Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT06265402
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrolaminar Block Versus Tab Block in Abdomioasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-11', 'studyFirstSubmitDate': '2024-02-11', 'studyFirstSubmitQcDate': '2024-02-11', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total dose of morphine consumption in the first postoperative 24hours', 'timeFrame': 'First 24hours', 'description': 'Total dose of morphine consumption in the first postoperative 24hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Block']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the analgesic efficacy of Us guided retrolaminar block versus transversus abdominis plane block in patient under going abdominal plastic surgery', 'detailedDescription': 'Pain from intra abdominal surgery is a combination of somatic and visceral pain visceral pain transmitted by autonomic nervous system via sympathetic fibers from plexuses in close proximity to the viscera them selves Regional anesthetic are commonly used to prevent or minimize these side effect the use of ultra sound nerve block are commonly use as apart of multimodal post operative analgesia The tab block is used to decrease the need of post operative analgesia in patient undergoing abdominal plastic surgery It was found an alternative approach to para vertebral block the retro laminar block is performed with us guided imaging to reduce pain post operative and need analgesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 90patients aged 18/65years of both sexes and asa physical status one two and three undergoing abdominal plastic surgery\n\nExclusion Criteria:\n\n* patient refusal Patient taking analgesia of chronic illness or have history of substance abuse Patient who are unable to describe their post operative pain Patient with history of coagulabathy Un cooperative patient Patient with known allergy to study drug Patient with infection at site needle puncture Patient with decompensated hepatic renal respiratory or cardiac disorder'}, 'identificationModule': {'nctId': 'NCT06265402', 'briefTitle': 'Retrolaminar Block Versus Tab Block in Abdomioasty', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison Between US Guided Retrolaminar Block and Transversus Abdominis Plane Block for Post Operative Analgesia in Patient Undergoing Abdominal Plastic Surgery', 'orgStudyIdInfo': {'id': '36264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Retrolaminar block in abdominal plastic surgery', 'description': 'In first group induction done with general anaesthia then Patient will receive bilateral us guided rertrolaminar block then bubivacane ,25%with dexa methasone 4mg as addiditive injected on the lamina at dose 20ml injected each side', 'interventionNames': ['Procedure: Tab block versus retrolaminar block in abdominal plastic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tab block as post operative analgesia in abdominal plastic surgery', 'description': 'In secound group after general anaesthia induction bilateral us guided tap block with ,25%bupivacaine with dexamethasone 4mg as addiditve injected on the lamina at doses 20ml in each side', 'interventionNames': ['Procedure: Tab block versus retrolaminar block in abdominal plastic surgery']}], 'interventions': [{'name': 'Tab block versus retrolaminar block in abdominal plastic surgery', 'type': 'PROCEDURE', 'description': 'i inject 20ml bupivacine either 4mg dead in each side', 'armGroupLabels': ['Retrolaminar block in abdominal plastic surgery', 'Tab block as post operative analgesia in abdominal plastic surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hadeel Elsagheer, Master', 'role': 'CONTACT'}], 'facility': 'TantaU U', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Hadeel Elsagheer, Master', 'role': 'CONTACT', 'email': 'Dodoelsagheer@gmail.com', 'phone': '01090884208'}, {'name': 'Tayseer Abdelrahman', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Hadeel Elsagheer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Elwakeel street qsm1', 'investigatorFullName': 'Hadeel Elsagheer', 'investigatorAffiliation': 'Tanta University'}}}}