Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT04317235
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2019-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012133', 'term': 'Respiratory Paralysis'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2020-03-20', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragmatic paralysis', 'timeFrame': 'Up to 48 hours', 'description': 'on x ray we look if there is an elevated diaphragm'}, {'measure': 'Pain relief', 'timeFrame': 'up to day 2 after operation', 'description': 'pain scale 1-10 score 1 no pain and 10 severe pain first by visiting patient before discharge twice and thereafter on the phone'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragmatic Paralysis']}, 'descriptionModule': {'briefSummary': 'Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries', 'detailedDescription': 'Ropivacaine for ultrasound-guided interscalene block: 3mL provide similar analgesia to 5mL with less diaphragmatic paralysis in shoulder arthroscopy surgeries with no toxicity and no adverse reaction or complications we targeted under echography each nerve to be blocked alone either to put around all the nerves a big volume'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA1-2\n\nExclusion Criteria:\n\n* ASA3-4 anticoagulant'}, 'identificationModule': {'nctId': 'NCT04317235', 'briefTitle': 'Ultrasound-guided Interscalene Block:3mL Ropi Provide Similar Analgesia to 5mL and Less Diaphragmatic Paralysis', 'organization': {'class': 'OTHER', 'fullName': 'Saint George Hospital'}, 'officialTitle': 'Ropivacaine for Ultrasound-guided Interscalene Block: 3mL Provide Similar Analgesia to 5mL With Less Diaphragmatic Paralysis in Shoulder Arthroscopy Surgeries', 'orgStudyIdInfo': {'id': 'SaintgeorgeH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '3 ml ropivacaine', 'description': 'interscalene block using 3 ml under ultrasound put medication on each nerve', 'interventionNames': ['Drug: Ropivacaine 0.5% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5 ml ropivacaine', 'description': 'interscalene block using 5 ml under ultrasound put medication on each nerve', 'interventionNames': ['Drug: Ropivacaine 0.5% Injectable Solution']}], 'interventions': [{'name': 'Ropivacaine 0.5% Injectable Solution', 'type': 'DRUG', 'otherNames': ['interscalene'], 'description': 'Is to put 3 ml or 5 ml and show the difference', 'armGroupLabels': ['3 ml ropivacaine', '5 ml ropivacaine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'hazem kafrouni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint George Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint George Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hazem Kafrouni', 'investigatorAffiliation': 'Saint George Hospital'}}}}