Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT04429893
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-31', 'studyFirstSubmitDate': '2020-06-08', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of the pain intensity', 'timeFrame': '24 hours', 'description': 'Pain assessment by visual analogue scale'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serratus anterior plane block', 'magnesium sulphate'], 'conditions': ['Cancer Breast', 'Chronic Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.', 'detailedDescription': 'Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult female patients\n* American Society Of Anesthesiologists (ASA) class I or II\n* scheduled for elective unilateral modified radical mastectomy\n\nExclusion Criteria\n\n* patient refusal\n* bilateral breast surgery\n* coagulation disorders\n* body mass index\\> 35\n* allergy to local anaesthetics or magnesium sulphate\n* severe respiratory or cardiac disorders\n* pre-existing neurological deficits\n* liver or renal insufficiency'}, 'identificationModule': {'nctId': 'NCT04429893', 'briefTitle': 'Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy', 'orgStudyIdInfo': {'id': '0304543'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group BM', 'description': 'The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.', 'interventionNames': ['Drug: magnesium sulphate', 'Drug: bupivicaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml', 'interventionNames': ['Drug: bupivicaine']}], 'interventions': [{'name': 'magnesium sulphate', 'type': 'DRUG', 'description': 'assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy', 'armGroupLabels': ['Group BM']}, {'name': 'bupivicaine', 'type': 'DRUG', 'description': 'assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy', 'armGroupLabels': ['Group B', 'Group BM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000000', 'city': 'Alexandria', 'state': 'Smouha', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rehab A. Abd Elaziz, Ass. Prof.', 'role': 'CONTACT', 'email': 'trcium2002@yahoo.com', 'phone': '01001073703', 'phoneExt': '020'}], 'facility': 'Rehab Abd Elraof Abd Elaziz', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Rehab A. Abd Elaziz, Ass. Prof.', 'role': 'CONTACT', 'email': 'trcium2002@yahoo.com', 'phone': '01001073703', 'phoneExt': '020'}], 'overallOfficials': [{'name': 'Rehab A. Abd Elaziz, Ass.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor of Anesthesia', 'investigatorFullName': 'rehab zayed', 'investigatorAffiliation': 'Alexandria University'}}}}