Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-28 @ 11:58 PM
Study NCT ID:
NCT04941235
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2021-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001134', 'term': 'Arm Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-26', 'studyFirstSubmitDate': '2021-06-20', 'studyFirstSubmitQcDate': '2021-06-20', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesic effect of each technique', 'timeFrame': '12 hour', 'description': 'using visual analogue scale for pain The patient is asked to express the degree of pain in numbers from 0-10, where 0 means no pain and 10 represents severe pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shoulder arthroscopy'], 'conditions': ['Shoulder and Upper Arm Injury']}, 'descriptionModule': {'briefSummary': 'There are different techniques of interscalene brachial plexus block, we aimed to evaluate the effectiveness of 3 of them as analgesia during shoulder arthroscopy surgery under general anesthesia.', 'detailedDescription': 'Prospective randomized controlled study\n\nThere were 4 groups included in our study:\n\nGroup N: nerve stimulator guided interscalene brachial plexus block was done Group U: ultrasound guided interscalene brachial plexus block was done Group NU: dual guidance (using both nerve stimulator and ultrasound) Group C: control group We assessed in each group: heart rate, noninvasive blood pressure, time needed for block, onset of sensory and motor power loss and their offset, and finally patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-65 years old.\n* Sex: Both sexes.\n* ASA I \\& II.\n\nExclusion Criteria:\n\n* \\- Patient refusal.\n* Bleeding disorders.\n* Damage or disease of the brachial plexus.\n* ASA more than II.\n* Pre-existing peripheral neuropathy.\n* Patients with neuromuscular diseases.\n* Patients with known hypersensitivity to drugs of the study.\n* Patients with local skin infection at the site of injection.\n* Psychiatric diseases interfering with evaluation of the block.'}, 'identificationModule': {'nctId': 'NCT04941235', 'briefTitle': 'The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'The Effectiveness of Different Techniques of Interscalene Brachial Plexus Block With General Anesthesia for Shoulder Arthroscopy', 'orgStudyIdInfo': {'id': '219:7/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NU group', 'description': 'Bth nerve stimulator and ultrasound guided interscalene brachial plexus block', 'interventionNames': ['Device: ultrasound and nerve stimulator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'U group', 'description': 'Ultrasound guided interscalene brachial plexus block', 'interventionNames': ['Device: ultrasound and nerve stimulator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N group', 'description': 'Nerve stimulator guided interscalene brachial plexus block', 'interventionNames': ['Device: ultrasound and nerve stimulator']}, {'type': 'NO_INTERVENTION', 'label': 'C group', 'description': 'No block only IV analgesics'}], 'interventions': [{'name': 'ultrasound and nerve stimulator', 'type': 'DEVICE', 'description': 'nerve stimulator and ultrasound guided interscalene brachial plexus block', 'armGroupLabels': ['N group', 'NU group', 'U group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of Medcine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Ahmed K Mohamed, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Shery Shehata Kyriacos', 'investigatorAffiliation': 'Minia University'}}}}