Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-04 @ 10:22 AM
Study NCT ID:
NCT06352333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parasagittal Vs Cornerpocket Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-07-31', 'releaseDate': '2025-07-15'}], 'estimatedResultsFirstSubmitDate': '2025-07-15'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Inclusion criteria:\n\n* 18to60 yearsold\n* ASA grade I to II\n* Elective upper limb surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-05', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Success rate', 'timeFrame': '1 year', 'description': 'Measrue number of failed and successful nerve blocks'}, {'measure': 'Complications', 'timeFrame': '1 year', 'description': 'Measure complications of the block'}], 'primaryOutcomes': [{'measure': 'Needle visibility in both approaches', 'timeFrame': '1 year', 'description': 'Measure the visibility of the needles in the ultrasound'}], 'secondaryOutcomes': [{'measure': 'Duration of sensory and motor block', 'timeFrame': '1 year', 'description': 'Measure the time of sensory and motor block start to happen after injecting local anathetics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brachial plexus block'], 'conditions': ['Supraclavicular Brachial Plexus Block']}, 'referencesModule': {'references': [{'pmid': '25376973', 'type': 'BACKGROUND', 'citation': 'Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.'}, {'pmid': '17196502', 'type': 'BACKGROUND', 'citation': 'Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.'}, {'pmid': '14570677', 'type': 'BACKGROUND', 'citation': 'Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14.'}, {'pmid': '19587618', 'type': 'BACKGROUND', 'citation': 'Duggan E, El Beheiry H, Perlas A, Lupu M, Nuica A, Chan VW, Brull R. Minimum effective volume of local anesthetic for ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 May-Jun;34(3):215-8. doi: 10.1097/AAP.0b013e31819a9542.'}]}, 'descriptionModule': {'briefSummary': 'Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.\n\nAlthough many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.\n\nEach approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .\n\nA supraclavicular block can provide effective surgical anesthesia of the forearm and hand.\n\nThe most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .\n\nA new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach', 'detailedDescription': 'After approval of research ethics committee of Sohag University hospital, a written consent will be taken from all participants to use their data for research and educational purposes The study will be carried on 80 participants who undergo elective upper limb surgery for a comparative study.\n\nIn this study the investigators will use A 22 G Spinal needle , a high frequency linear probe of US and 2 % lidocaine and 0.5% bupivacaine as local anathetics ,Every participant will be informed about advantages and disadvantages of the research and has the right to withdraw at any stage without negative impact on medical service production.\n\nFor both types of block:\n\nWide bored cannula is inserted,Monitoring is applied (pulse,Ecg,Bp) Oxygen mask 5 liters , Participants were positioned supine with the head turned to the non-operative Side ( contralateral side), and a pillow under the head and shoulder with the ipsilateral arm placed adducted by the patient side.\n\nAfter that we sterilize the skin and apply a local anesthetic (2-3 ml of2% lidocaine).\n\nThe total volume of the local anesthetic mixture was 30 ml (10 ml of 2% lidocaine mixed with 20 ml of 0.5% bupivacine ) Then participants will be divided randomly into 2 groups ,each group 40 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 60 years old\n* ASA grade I to II\n* Elective upper limb surgery\n\nExclusion Criteria:\n\n* Patient refusal.\n* Patient with neurological deficit in the limb of surgery\n* Patients with psychiatric disease.\n* Coagulopathy.\n* Morbid obesity.\n* Known allergy to used local anathetics\n* Local infection at the block site.'}, 'identificationModule': {'nctId': 'NCT06352333', 'briefTitle': 'Parasagittal Vs Cornerpocket Approaches', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Parasagittal Vs Cornerpocket Approaches for Ultrasound Guided Supraclavicular Brachial Plexus Block A Comparative Study', 'orgStudyIdInfo': {'id': 'Parasagittal Vs Cornerpocket'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'Cornerpocket supraclavicular ultrasound guided brachial plexus block', 'interventionNames': ['Procedure: supraclavicular ultrasound guided brachial plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'Parasagital supraclavicular ultrasound guided brachial plexus block', 'interventionNames': ['Procedure: supraclavicular ultrasound guided brachial plexus block']}], 'interventions': [{'name': 'supraclavicular ultrasound guided brachial plexus block', 'type': 'PROCEDURE', 'description': 'two approaches of ultrasound guided supraclavicular brachial plexus block in upper limb surgery : the cornerpocket supraclavicular brachial plexus block and parasagittal supraclavicular brachial plexus block', 'armGroupLabels': ['group A', 'group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag university Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Nada t Ahmed, resident', 'role': 'CONTACT', 'email': 'nada_abdelrohman@yahoo.com', 'phone': '01069459544'}, {'name': 'Wael A Mahmoud, assistant professor', 'role': 'CONTACT', 'phone': '01020363508'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigaror', 'investigatorFullName': 'Nada Thabet Ahmed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-15', 'type': 'RELEASE'}, {'date': '2025-07-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nada Thabet Ahmed, Principle investigaror, Sohag University'}}}}