Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT03940469
Status:
COMPLETED
Last Update Posted:
2019-05-07
First Post:
2019-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'both the patients and the observer were blind to the treatment groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-05-06', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in postoperative analgesia', 'timeFrame': 'During first 2 days after surgery', 'description': 'Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Postoperative analgesic requirement', 'timeFrame': 'During first 2 days after surgery', 'description': 'Total amount of paracetamol required in mg'}, {'measure': 'Hemodynamic parameter', 'timeFrame': 'During first 2 days after surgery', 'description': 'Heart rate'}, {'measure': 'Hemodynamic parameter', 'timeFrame': 'During first 2 days after surgery', 'description': 'Mean arterial blood pressure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Dexamethasone', 'Interscalene'], 'conditions': ['Postoperative Analgesia', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.', 'detailedDescription': 'Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sixty healthy patients ASA I-II\n* Aged 18-60 years\n* Of both sexes\n* Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.\n\nExclusion Criteria:\n\n* Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists\n* All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists\n* Pregnant women\n* Psychiatric patients\n* Patients with a previous history or clinical evidence of central or peripheral neurological disease\n* Coagulopathy or anticoagulant/antiaggregant therapy\n* Contralateral phrenic nerve paresis\n* Patients who have an infection at the site of the block.\n* Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.'}, 'identificationModule': {'nctId': 'NCT03940469', 'acronym': 'IBBB', 'briefTitle': 'Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Interscalene Dexmedetomidine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.', 'interventionNames': ['Drug: Saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone group', 'description': 'received 35ml levobupivacaine+8mg dexamethasone', 'interventionNames': ['Drug: Dexamethasone Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmeteomidine group', 'description': 'received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.', 'interventionNames': ['Drug: Dexmedetomidine Hydrochloride']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'otherNames': ['normal saline'], 'description': '2 ml normal saline', 'armGroupLabels': ['Control group']}, {'name': 'Dexamethasone Injection', 'type': 'DRUG', 'otherNames': ['dexamethsone'], 'description': '8 mg dexamethasone', 'armGroupLabels': ['Dexamethasone group']}, {'name': 'Dexmedetomidine Hydrochloride', 'type': 'DRUG', 'otherNames': ['dexmedetomidine'], 'description': '100 microgram dexmedetomidine', 'armGroupLabels': ['Dexmeteomidine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Shibīn al Kawm', 'state': 'Monufia Governorate', 'country': 'Egypt', 'facility': 'Ashraf Eskandr', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'overallOfficials': [{'name': 'mamdouh e lotfy, m.d.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'emeritus professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mamdoh Elsayed Lotfy', 'class': 'UNKNOWN'}, {'name': 'Osama Abdallah Elsharkawy', 'class': 'UNKNOWN'}, {'name': 'Basma Abdelhamid Fathy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia, ICU', 'investigatorFullName': 'ashraf magdy eskandr', 'investigatorAffiliation': 'Menoufia University'}}}}