Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-21 @ 6:23 AM
Study NCT ID:
NCT02001259
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2013-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Epidural Steroid for Controlling Pain After Primary TKA
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2013-11-27', 'studyFirstSubmitQcDate': '2013-11-27', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'complication of epidural triamcinolone', 'timeFrame': '2 weeks'}, {'measure': 'range of motion of the knee', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'post-operative pain', 'timeFrame': '3 months', 'description': 'measured with VAS for pain (VAS at rest and on motion)'}], 'secondaryOutcomes': [{'measure': 'functional knee score', 'timeFrame': '3 months', 'description': 'measured with WOMAC'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['post-operative pain control', 'total knee arthroplasty', 'epidural steroid injection'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA', 'detailedDescription': 'Epidural triamsinolone can reduce postoperative pain and longer duration of pain control after TKA'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty\n* 50-85 years old\n* ASA class 1-3\n\nExclusion Criteria:\n\n* unable to perform epidural anaesthesia\n* history of drug allergies: lidocaine, steroid\n* renal impairment (CrCl \\<30 mL/min)\n* liver impairment\n* cognitive function disorders\n* displacement of epidural catheter'}, 'identificationModule': {'nctId': 'NCT02001259', 'briefTitle': 'Efficacy of Epidural Steroid for Controlling Pain After Primary TKA', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial', 'orgStudyIdInfo': {'id': 'orthoTU05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epidural lidocaine', 'description': 'epidural lidocaine: 3 mL of 1% lidocaine with adrenaline and 3 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery', 'interventionNames': ['Drug: epidural lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'epidural triamsinolone', 'description': 'epidural triamsinolone: 40 mg of triamsinolone (1 mL), 2.5 mL of 1% lidocaine with adrenaline and 2.5 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery', 'interventionNames': ['Drug: epidural triamsinolone']}], 'interventions': [{'name': 'epidural triamsinolone', 'type': 'DRUG', 'otherNames': ['epidural steroid'], 'description': 'add drugs into catheter at 48 hr after surgery', 'armGroupLabels': ['epidural triamsinolone']}, {'name': 'epidural lidocaine', 'type': 'DRUG', 'otherNames': ['epidural xylocaine'], 'description': 'add into catheter at 48 hr after surgery', 'armGroupLabels': ['Epidural lidocaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '066', 'city': 'Khlong Luang', 'state': 'Changwat Pathum Thani', 'country': 'Thailand', 'facility': 'department of orthopaedic surgery, Faculty of medicine, Thammasat university', 'geoPoint': {'lat': 14.06467, 'lon': 100.64578}}], 'overallOfficials': [{'name': 'Supakit Kanitnate, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'orthopaedic department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'orthopaedic department', 'investigatorFullName': 'Supakit Kanitnate', 'investigatorAffiliation': 'Thammasat University'}}}}