Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
Study NCT ID:
NCT03944759
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2019-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Serratus Anterior Plane Block Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2019-05-06', 'studyFirstSubmitQcDate': '2019-05-08', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to first analgesic requirements in minutes', 'timeFrame': 'change from base line for 24 hours', 'description': 'time to first analgesic requirements in minutes by the patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'Breast cancer is the main common cancer among females. . Inadequate control of pain may later develop into chronic pain syndrome (paraesthesias, phantom breast pain, and intercostobrachial neuralgia) in 25-40% of the patients .', 'detailedDescription': 'The aim of this study is to compare the efficacy of ultrasound-guided serratus anterior plane block with bupivacaine/ magnesium versus bupivacaine/ nalbuphine in breast cancer surgery.\n\nPatients and methods nclusion criteria:\n\n-ASA I and II female patients, age 25-60 undergoing breast cancer surgery\n\nExclusion criteria:\n\n* Patient refusal\n* Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)\n* Allergy to the drugs used in the study\n* Chronic pain therapy,\n* BMI more than 30 kg/m2'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I and II female patients, age 25-60 undergoing breast cancer surgery\n\nExclusion Criteria:\n\n* -Patient refusal\n* Contraindications for regional blocks (eg. Infection at the injection site, coagulopathy)\n* Allergy to the drugs used in the study\n* Chronic pain therapy,\n* BMI more than 30 kg/m2'}, 'identificationModule': {'nctId': 'NCT03944759', 'briefTitle': 'Efficacy of Serratus Anterior Plane Block Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Efficacy of Serratus Anterior Plane Block Using Bupivacaine/Magnesium Sulphate Versus Bupivacaine/Nalbuphine for Mastectomy: a Randomized Double Blinded Comparative Study', 'orgStudyIdInfo': {'id': 'FMBSURECS/30042019/Ali'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GBM:( bupivacaine/magnesium sulphate)', 'description': 'serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.\n\nGBM:( bupivacaine/magnesium sulphate): will receive bupivacaine 30 ml 0.25 and 500 mg magnesium sulphate', 'interventionNames': ['Procedure: serratus anterior plan block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GBN: ( bupivacaine/nalpuphin)', 'description': 'serratus plane block will performed in the supine position under strict aseptic conditions before induction of anesthesia.. ( bupivacaine/nalpuphin):received bupivacaine 30 ml 0.25 % and nalpuphine 0.2mg/kg.', 'interventionNames': ['Procedure: serratus anterior plan block']}], 'interventions': [{'name': 'serratus anterior plan block', 'type': 'PROCEDURE', 'description': 'serratus anterior plan block', 'armGroupLabels': ['GBM:( bupivacaine/magnesium sulphate)', 'GBN: ( bupivacaine/nalpuphin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11391', 'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Faculty Of Medicine, Beni-Suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'overallOfficials': [{'name': 'Doaa Rashwan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine Beni-Suef University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after registration for ever', 'ipdSharing': 'YES', 'description': 'the protocol', 'accessCriteria': 'on the web page\n\n\\-'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'doaa rashwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant profesor Doaa Rashwan', 'investigatorFullName': 'doaa rashwan', 'investigatorAffiliation': 'Beni-Suef University'}}}}