Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:51 PM
Study NCT ID:
NCT05008367
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-23', 'size': 974054, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-23T09:47', 'hasProtocol': True}]}}, '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': 485}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-06', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subgroup analysis on heterogeneity in intervention effect of age', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'Age (years): \\> 65 vs. ≤ 65'}, {'measure': 'Subgroup analysis on heterogeneity in intervention effect of sex', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'Sex: male vs. female'}, {'measure': 'Subgroup analysis on heterogeneity in intervention effect of ASA group', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'ASA group classification: I+II vs. III'}, {'measure': 'Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'VAS (mm): \\> 30 vs. ≤ 30'}, {'measure': 'Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'VAS (mm): \\> 30 vs. ≤ 30'}, {'measure': 'Subgroup analysis on heterogeneity in intervention effect of type of anesthesia', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'Type of anesthesia: spinal vs. general Anesthesia+Converted to general anesthesia'}, {'measure': 'Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'Prior daily use of paracetamol or NSAID: either parecetamol or NSAID vs. neither parecetamol or NSAID'}], 'primaryOutcomes': [{'measure': 'Cumulative usage of morphine 0-48 hours postoperatively', 'timeFrame': 'Time Frame: 0-48 hours postoperatively', 'description': 'Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.', 'detailedDescription': 'Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in the DEX-2-TKA-trial'}, 'identificationModule': {'nctId': 'NCT05008367', 'briefTitle': 'Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Naestved Hospital'}, 'officialTitle': 'Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SM1-KAKG-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A', 'description': '24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B', 'description': '24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day', 'interventionNames': ['Drug: Dexamethasone', 'Drug: Isotonic saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day', 'interventionNames': ['Drug: Isotonic saline']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': '24 mg intravenous Dexamethasone (6 ml)', 'armGroupLabels': ['Treatment A', 'Treatment B']}, {'name': 'Isotonic saline', 'type': 'DRUG', 'description': '6 ml of isotonic saline', 'armGroupLabels': ['Placebo', 'Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Brøndby', 'country': 'Denmark', 'facility': 'Gildhøj Privathospital', 'geoPoint': {'lat': 55.6455, 'lon': 12.41008}}, {'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Sjællands Universitetshospital, Køge', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': '4700', 'city': 'Næstved', 'country': 'Denmark', 'facility': 'Næstsved Sygehus', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense Universitetshospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Naestved Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen Trial Unit, Center for Clinical Intervention Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}