Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06188156
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-30', 'studyFirstSubmitDate': '2023-12-10', 'studyFirstSubmitQcDate': '2023-12-30', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Post-operative Pain', 'timeFrame': 'First 24-hour analgesic after Mastectomy', 'description': 'Assessment of the pain post-operatively in patients with pain assessed by VAS score : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thoracic epidural blockage', 'Ultrasound Guided Serratus Anterior Plane Block', 'Pectoral Nerve Block II', 'Radical Mastectomy'], 'conditions': ['Anesthesia', 'Radical Mastectomy']}, 'descriptionModule': {'briefSummary': 'Modified Radical Mastectomy accounts for 31% of all breast surgeries and considered the fundamental surgical management for breast cancer. Nearly 40-60% of patients experience severe acute postoperative pain. This pain might persist for 6-12 months and result in post-mastectomy pain syndrome and complex regional pain syndrome (causalgia)', 'detailedDescription': 'There are some local or regional nerve blocks in breast surgeries performed as core components of multimodal analgesia and enhanced recovery after surgery (ERAS), including thoracic epidural (TEB), interscalene brachial plexus, paravertebral, ultrasound-guided pectoral nerve block ( PECS II ), ultrasound-guided serratus anterior plane block (SAPB) and erector spinae plane block .\n\nThoracic epidural (TEB) is the gold standard technique following breast surgery, but there is still a problem with the adequacy of thoracic and axillary blockage during lymph node dissection .\n\nModified PECS\'s block" or PECS block type II aimed to block the axilla that is vital for axillary clearances and the intercostal nerves, necessary for wide excisions which can provide analgesia after breast surgery.\n\nIn the ultrasound-guided serratus anterior plane block (SAPB), the local anesthetic (LA) is injected in the compartment between the serratus anterior and latissimus dorsi muscles. SAPB anesthetizes the intercostobrachial nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve thus providing analgesia for breast and lateral thoracic wall surgeries'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 35-65 years.\n* BMI 18.5 - 25 kg/m2.\n* American Society of Anesthesiologists (ASA) I-II.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Coagulopathy.\n* Mental and psychiatric disorders.\n* History of chronic pain.\n* Hypersensitivity or contraindication to any of study drugs\n* Previous chemotherapy.'}, 'identificationModule': {'nctId': 'NCT06188156', 'briefTitle': 'Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Analgesic Efficacy of Ultrasound Guided Serratus Anterior Plane Block and Pectoral Nerve Block II Compared to Thoracic Epidural Block After Unilateral Modified Radical Mastectomy', 'orgStudyIdInfo': {'id': 'Ahmed Elbasuni Ali'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic Epidural Block(Group 1)', 'description': 'About 33 Patients will receive thoracic epidural block with an injection of a single shot of 15ml of 0.25% bupivacaine between T4 and T5 vertebrae.', 'interventionNames': ['Procedure: Anethesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound Guided Sserratus Anterior Plane Block (Group 2)', 'description': 'About 33 Patients will receive Ultrasound Guided Sserratus Anterior Plane Block( SAPB) with an injection of 30 ml bupivacaine 0.25% .', 'interventionNames': ['Procedure: Anethesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound Guided Pectoral Nerve Block (Group 3)', 'description': 'About 33 Patients will receive Ultrasound Guided Pectoral Nerve Block ( PECS II) with an injection of 20 ml bupivacaine 0.25% of pectoral-minor above the Serratus anterior muscle.', 'interventionNames': ['Procedure: Anethesia']}], 'interventions': [{'name': 'Anethesia', 'type': 'PROCEDURE', 'description': 'To assess the effectiveness of thoracic epidural blockage versus ultrasonic guided PECS II block versus ultrasound guided serratus anterior plane block for postoperative pain management in modified radical mastectomy.', 'armGroupLabels': ['Thoracic Epidural Block(Group 1)', 'Ultrasound Guided Pectoral Nerve Block (Group 3)', 'Ultrasound Guided Sserratus Anterior Plane Block (Group 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Abdelgawad, Assist.Prof', 'role': 'CONTACT', 'email': 'abosoad.mohamed2017@gmail.com', 'phone': '+201091945931'}, {'name': 'Mohamed Abdelgawad Aboelsuod, Assist.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Al-Azhar University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Elbasuni, MSC', 'role': 'CONTACT', 'email': 'ahmedelbasuni86@yahoo.com', 'phone': '+201125373436'}], 'overallOfficials': [{'name': 'Alaa Aldine Mahmoud Said, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Al-Azhar University, Faculty of medicine for boys'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia, intensive care and pain management Faculty of Medicine', 'investigatorFullName': 'mohamed A Aboelsuod, MD', 'investigatorAffiliation': 'Al-Azhar University'}}}}