Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT03853460
Status:
UNKNOWN
Last Update Posted:
2019-11-05
First Post:
2019-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'both patients and data collector will be unaware of the group nature'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-02', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': '24 hours', 'description': 'Visual analogue score from 0 to 10 will be used to assess pain postoperative. 0 means no pain. 10 is worst pain'}], 'secondaryOutcomes': [{'measure': 'anaesthetic consumption', 'timeFrame': '4 hours', 'description': 'calculating the total anaesthetic MAC consumed'}, {'measure': 'diaphragmatic excursion', 'timeFrame': '24 hours', 'description': 'assessment of diaphragmatic excursion preoperative and postoperative using low frequency ultrasound probe'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Acute']}, 'descriptionModule': {'briefSummary': 'ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.', 'detailedDescription': 'ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective surgery\n* patients between 30 and 60 years\n\nExclusion Criteria:\n\n* coagulopathy\n* infection at insertion site\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT03853460', 'briefTitle': 'Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy', 'orgStudyIdInfo': {'id': 'QLMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'epidural group', 'description': 'ULTRASOUND GUIDED thoracic epidural at T 12 WILL BE INSERTED before anaesthesia induction', 'interventionNames': ['Procedure: epidural catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'quadus lumborum group', 'description': 'bilateral ultrasound guided quadratus lumborum catheter will be inserted before anaesthesia induction', 'interventionNames': ['Procedure: nerve block catheter']}], 'interventions': [{'name': 'epidural catheter', 'type': 'PROCEDURE', 'description': 'ultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural', 'armGroupLabels': ['epidural group']}, {'name': 'nerve block catheter', 'type': 'PROCEDURE', 'description': 'ultrasound guided placement of bilateral quadratus lumborum catheters', 'armGroupLabels': ['quadus lumborum group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'rasha hamed, MD', 'role': 'CONTACT', 'email': 'amira_salem2015@yahoo.com', 'phone': '0882413201'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '71111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'rasha hamed', 'role': 'CONTACT', 'email': 'rashaahmed11@yahoo.com', 'phone': '01000440773'}, {'name': 'saeed elsawy', 'role': 'CONTACT', 'email': 'saeedelsawy17@gmail.com', 'phone': '01030072161'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anaesthesia and pain management', 'investigatorFullName': 'Rasha Hamed', 'investigatorAffiliation': 'Assiut University'}}}}