Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 11:23 PM
Study NCT ID:
NCT06262893
Status:
RECRUITING
Last Update Posted:
2025-04-22
First Post:
2023-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative analgesia by visual analog scale (VAS).', 'timeFrame': '48 hours', 'description': "The\n\nprimary outcome of this study will be to evaluate and compare between suprascapular-supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on postoperative analgesia by vas score during 48h postoperatively ( 2h , 6h , 12h, 24h and 48h).\n\nThe VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')."}], 'secondaryOutcomes': [{'measure': 'Diaphragmatic excursion', 'timeFrame': '1hour postoperatively', 'description': 'Assessment of diaphragmatic excursion by ultrasound preoperatively and 1hour postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Arthroscopy Blocks', 'Dexamethasone']}, 'descriptionModule': {'briefSummary': 'In this study the investigators aim to compare the effect of the suprascapular- supraclavicular nerve block in association with dexamethasone to that of the interscalene brachial plexus block on analgesic effect during arthroscopic shoulder surgery, as postoperative pain scores ,postoperative consumption of analgesic rescue medications and diaphragmatic excursion assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA status 1,2.\n\n * Age 18 years or older\n * Elective shoulder arthroscopic surgery under general anesthesia and nerve block performed preoperatively.\n\nExclusion Criteria:\n\n* • Patient refusal\n\n * Serious cardiac arrhythmias (including atrial fibrillation) or unstable coronary artery disease.\n * Use of drugs that act on the autonomic nervous system (including β- blockers).\n * Coagulation disorders..\n * Anatomical disorders and/or neuropathic disease.\n * BMI above 40.\n * History of substance abuse.\n * Chronic use of psychotropic and/or opioid.\n * History of psychiatric diseases needing treatment.\n * Allergy to any drug in the study protocol.\n * Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level).'}, 'identificationModule': {'nctId': 'NCT06262893', 'briefTitle': 'Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Dexamethasone Adjuvant in Combined Supraclavicular Block and Suprascapular Block Versus Interscalene Block in Patients Undergoing Shoulder Arthroscopy', 'orgStudyIdInfo': {'id': 'Shoulder nerve blocks'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interscalene block in shoulder arthroscopy', 'interventionNames': ['Procedure: Shoulder arthroscopy blocks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined Supraclavicular block and suprascapular block in shoulder arthroscopy', 'interventionNames': ['Procedure: Shoulder arthroscopy blocks']}], 'interventions': [{'name': 'Shoulder arthroscopy blocks', 'type': 'PROCEDURE', 'description': 'Effect of dexamethasone adjuvant in combined supraclavicular block and suprascapular block versus Interscalene block in patients undergoing shoulder arthroscopy.', 'armGroupLabels': ['Combined Supraclavicular block and suprascapular block in shoulder arthroscopy', 'Interscalene block in shoulder arthroscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Assiut University', 'role': 'CONTACT'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mohamed Ahmed', 'role': 'CONTACT', 'email': 'mohamedelkhatib90@gmail.com', 'phone': '01151994269'}, {'name': 'Mohamed Talaat', 'role': 'CONTACT', 'phone': '+20 106 201 2031'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}