Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT01414569
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2011-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexamethasone for Pain After Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, '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': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-03', 'studyFirstSubmitDate': '2011-08-09', 'studyFirstSubmitQcDate': '2011-08-10', 'lastUpdatePostDateStruct': {'date': '2013-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score by numeric rating scale', 'timeFrame': 'At 8 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Use of analgesics', 'timeFrame': 'During hospital stay, about 4 hours', 'description': 'Need for supplemental analgesic medication during stay in recovery on the day of operation, until discharge.'}, {'measure': 'Pain score by numeric rating scale', 'timeFrame': 'At about 8 a.m. on the first postoperative day', 'description': 'On the morning of the first postoperative day, the self-evaluated level of pain as assessed by numeric rating scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Shoulder Impingement Syndrome', 'Arthritis']}, 'referencesModule': {'references': [{'pmid': '24825530', 'type': 'DERIVED', 'citation': 'Bjornholdt KT, Monsted PN, Soballe K, Nikolajsen L. Dexamethasone for pain after outpatient shoulder surgery: a randomised, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2014 Jul;58(6):751-8. doi: 10.1111/aas.12333. Epub 2014 May 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a dose of 40 mg dexamethasone is more effective as pain treatment than the currently used dose of 8 mg after arthroscopic shoulder surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arthroscopic subacromial decompression and/or acromioclavicular resection\n* General anaesthesia\n* Daysurgery, Horsens Hospital\n\nExclusion Criteria:\n\n* Incompetent\n* Pregnant\n* Age under 18 or over 90 years\n* Allergy toward dexamethasone\n* Diabetes\n* Active gastric ulcer\n* Untreated hypertension\n* Glaucoma\n* Daily use of glucocorticoids or strong opioids\n* Daily use of analgesics for unrelated illness\n* Myasthenia gravis\n* Mitochondrial disorders'}, 'identificationModule': {'nctId': 'NCT01414569', 'briefTitle': 'Dexamethasone for Pain After Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'High Dose Dexamethasone as Pain Treatment After Arthroscopic Shoulder Surgery: A Randomised, Blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'KTB-002'}, 'secondaryIdInfos': [{'id': '2011-003082-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '8 mg dexamethasone', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, saline', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': '40 mg dexamethasone', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Fortecortin'], 'description': 'Singe dose preoperatively in 100 ml saline intravenously', 'armGroupLabels': ['40 mg dexamethasone', '8 mg dexamethasone', 'Placebo, saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8700', 'city': 'Horsens', 'country': 'Denmark', 'facility': 'Horsens Hospital', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}], 'overallOfficials': [{'name': 'Karen T Bjørnholdt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University, Horsens Hospital'}, {'name': 'Kjeld Søballe, Prof. dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}, {'name': 'Lone Nikolajsen, ph.d., MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Horsens Hospital', 'class': 'OTHER'}, {'name': 'Central Denmark Region', 'class': 'OTHER'}, {'name': 'The Hede Nielsen Family Foundation', 'class': 'OTHER'}, {'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}