Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT02760459
Status:
UNKNOWN
Last Update Posted:
2016-10-10
First Post:
2016-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, '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': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'lastUpdateSubmitDate': '2016-10-07', 'studyFirstSubmitDate': '2016-05-01', 'studyFirstSubmitQcDate': '2016-05-01', 'lastUpdatePostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified WOMAC scores for pain at 12 weeks postoperative', 'timeFrame': '12 weeks', 'description': 'using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scales for pain during a five-meter walk (0-100)', 'timeFrame': 'postoperatively at 24, 30, 48, 54, 72 hrs'}, {'measure': 'Visual analogue scales for pain during 45 degree active knee flexion (0-100)', 'timeFrame': 'postoperatively at 6, 24, 30, 48, 54, 72 hrs'}, {'measure': 'Visual analogue scales for current pain at rest in a supine position (0-100)', 'timeFrame': 'postoperatively at 6, 24, 30, 48, 54, 72 hrs'}, {'measure': 'Visual analogue scales for maximum pain at rest over the last 24 hours and minimum pain at rest over the last 24 hours (0-100)', 'timeFrame': 'postoperatively at 0-24, 24-48, 48-72 hrs'}, {'measure': 'Visual analogue scale values for nausea (0-100)', 'timeFrame': 'postoperatively at 6, 24, 30, 48, 54, 72 hrs'}, {'measure': 'Opioid consumption (mg.)', 'timeFrame': 'during the first 0-24, 24-48, and 48-72 hrs'}, {'measure': 'Anti-emetic medicine consumption (mg.)', 'timeFrame': 'during the first 0-24, 24-48, and 48-72 hrs'}, {'measure': 'Maximum degree of active knee flexion', 'timeFrame': 'postoperatively at 24, 48, 72 hrs, 2 weeks, 6 weeks, and 12 weeks'}, {'measure': 'Modified WOMAC scores for pain', 'timeFrame': 'postoperatively at weeks 2 and 6', 'description': 'using the modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis questionnaire'}, {'measure': 'Wound complications', 'timeFrame': 'evaluated postoperatively at weeks 2, 6 and 12'}]}, 'conditionsModule': {'conditions': ['Osteoarthritis of the Knee']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "1. Callahan CM, Drake BG, Heck DA, Dittus RS. Patient outcomes following tricompartmental total knee replacement. A meta-analysis. JAMA. 1994;271(17):1349-57. 2. Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014;22(8):1744-58."}, {'pmid': '39702151', 'type': 'DERIVED', 'citation': 'Kitcharanant N, Leurcharusmee P, Atthakomol P, Jingjit W. Perioperative intravenous dexamethasone did not reduce the severity of persistent postsurgical pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. J Orthop Surg Res. 2024 Dec 19;19(1):854. doi: 10.1186/s13018-024-05362-y.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.', 'detailedDescription': 'It is not clear whether perioperative intravenous Dexamethasone has an effect on severity of persistent postsurgical pain (PPSP) after total knee arthroplasty (TKA). The research hypothesis is that TKA patients experience less severe PPSP after administration of perioperative intravenous Dexamethasone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 40 years (45)\n* Primary knee osteoarthritis diagnosed using the American College of Rheumatology criteria (46)\n* Undergoing elective, primary and unilateral total knee arthroplasty\n* American Society of Anesthesiology (ASA) physical status class 1-3\n* BMI \\< 40 kg/m2\n\nExclusion Criteria:\n\n* History of active rheumatic diseases\n* History of previous musculoskeletal injury of the same knee for excluding patients with secondary knee osteoarthritis\n* History of previous surgery on the same knee\n* History of adverse effects from medications to be used in this study\n* Contraindication to spinal anesthesia\n* History of psychiatric disorders or cognitive impairment\n* Contraindication to corticosteroid agents\n* Poorly controlled diabetes mellitus (HbA1C \\> 7.5)\n* Poorly controlled hypertension\n* History of ischemic heart disease or peripheral arterial disease or cerebrovascular disease\n* Hepatic insufficiency (Child-Pugh score \\> 5)\n* Renal insufficiency (Creatinine clearance \\< 30 mL/min)\n* History of cataracts or glaucoma or ocular hypertension\n* History of steroid or immunosuppressive drug use within 6 months of surgery'}, 'identificationModule': {'nctId': 'NCT02760459', 'briefTitle': 'Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'ORT-2558-03245'}, 'secondaryIdInfos': [{'id': '054/2559', 'type': 'OTHER_GRANT', 'domain': 'Faculty of medicine, Chiangmai university fund'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': 'The steroid group will receive Dexamethasone 10 mg IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of Dexamethasone 10 mg IV postoperatively at 24 and 48 hrs.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The control group will receive sterile normal saline solution, serving as placebo, IV immediately prior to induction of spinal anesthesia and will receive a second and third dose of placebo IV postoperatively 24 and 48 hrs. Both Dexamethasone and normal saline solution will be administered as an IV push.', 'interventionNames': ['Drug: Normal saline solution']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Normal saline solution', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'state': 'ChiangMai', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Nitchanant Kitchatanant', 'role': 'CONTACT', 'email': 'nk_win@hotmail.com', 'phone': '+66871071133'}], 'facility': 'Department of Orthopedics, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'centralContacts': [{'name': 'Nitchanant Kitcharanant, MD', 'role': 'CONTACT', 'email': 'nk_win@hotmail.com', 'phone': '+66871071133'}], 'overallOfficials': [{'name': 'Nitchanant Kitcharanant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopedics, Faculty of Medicine, Chiang Mai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nitchanant Kitcharanant', 'investigatorAffiliation': 'Chiang Mai University'}}}}