Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-02-17 @ 6:09 PM
Study NCT ID:
NCT02026050
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2013-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-03', 'studyFirstSubmitDate': '2013-12-30', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analgesic consumption', 'timeFrame': 'postoperative 1 day', 'description': 'morphine consumption (patient controlled analgesia procedure) was recorded'}], 'secondaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': 'postoperative 1 day', 'description': 'Visual analog scale on rest and movement was recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dexamethasone', 'intraarticular injection', 'interscalene brachial plexus block'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'the aim of this study was to investigate the analgesic efficacy of intra articular dexamethasone administration for arthroscopic shoulder surgery.', 'detailedDescription': 'shoulder surgery can be very painful and interscalene brachial plexus block is the gold standard in the management of acute pain after shoulder surgery. various local anaesthetic mixtures can be used to prolong local anaesthesia duration and epinephrine , opioids and dexamethasone are frequently used for this purpose. dexamethasone has also been found the prolong the duration of lidocaine axillary blocks and intravenous regional anaesthesia. intraarticular administration of medicines can be used for management of joint pain and opioids , local anaesthetics and dexamethasone are used for this purpose.In addition, there are no studies available to compare the different treatment methods used in clinical practice directly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18-65 years\n* arthroscopic shoulder surgery\n* no known allergies to drugs\n* ASA 1-2 patients\n\nExclusion Criteria:\n\n* history of diabetes\n* history of chronic pain treatment\n* pregnancy\n* severe bronchopulmonary disease\n* systemic glucocorticoid use'}, 'identificationModule': {'nctId': 'NCT02026050', 'briefTitle': 'Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Phase 4 Study of Comparison of Postoperative Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus Blockade for Arthroscopic Shoulder Surgery', 'orgStudyIdInfo': {'id': '2013/639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intraarticular dexamethasone', 'description': 'interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2 ml serum phsyologic and after surgery 2 ml 8 mg dexamethasone+ 8 ml serum phsyologic administration for intraarticular', 'interventionNames': ['Procedure: intraarticular dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'interscalene dexamethasone', 'description': 'interscalene brachial plexus was preoperative performed 30 ml 0.5 % bupivacaine added 2 ml 8mg dexamethasone and after surgery 10 ml serum phsyologic administration for intraarticular', 'interventionNames': ['Procedure: interscalene dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'serum phsyologic', 'description': 'interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2ml serum phsyologic and after surgery 10 ml serum phsyologic administration for intraarticular', 'interventionNames': ['Procedure: serum phsyologic']}], 'interventions': [{'name': 'intraarticular dexamethasone', 'type': 'PROCEDURE', 'otherNames': ['dekort'], 'description': '2ml 8 mg dexamethasone administration for intraarticular', 'armGroupLabels': ['intraarticular dexamethasone']}, {'name': 'interscalene dexamethasone', 'type': 'PROCEDURE', 'otherNames': ['dekort'], 'description': '2ml 8 mg dexamethasone administration interscalene brachial plexus added 30 ml 0.5 % bupivacaine', 'armGroupLabels': ['interscalene dexamethasone']}, {'name': 'serum phsyologic', 'type': 'PROCEDURE', 'description': 'interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2ml serum phsyologic and after surgery 10 ml serum phsyologic administration for intraarticular', 'armGroupLabels': ['serum phsyologic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38039', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes university hospital', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Fatih M KURT, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TC Erciyes University'}, {'name': 'Gülen GÜLER, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TC Erciyes University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Fatih Mehmet Kurt', 'investigatorAffiliation': 'TC Erciyes University'}}}}