Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-05 @ 7:05 PM
Study NCT ID:
NCT03034733
Status:
TERMINATED
Last Update Posted:
2018-11-29
First Post:
2017-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery
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'}]}}, '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': 27}}, 'statusModule': {'whyStopped': 'Principal investigator (M.K.) left for another workplace. Patient recruitment more difficult than expected.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-27', 'studyFirstSubmitDate': '2017-01-03', 'studyFirstSubmitQcDate': '2017-01-24', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'blood glucose, mmol/l', 'timeFrame': 'at preoperative visit, at induction of anesthesia, postoperatively: at 2 hours, at 8 hours, at 24 hours, at 32 hours, at 48 hours', 'description': 'blood sample'}, {'measure': 'inflammatory reaction, c-reactive protein (CRP)', 'timeFrame': 'preoperative, postoperatively: at 24 hours, 48 hours', 'description': 'blood sample'}, {'measure': 'wound complication, yes/no', 'timeFrame': 'postoperatively up to 90 days', 'description': 'wound complication, yes/no'}, {'measure': 'wound infection, yes/no', 'timeFrame': 'postoperatively up to 90 days', 'description': 'wound infection, yes/no'}], 'primaryOutcomes': [{'measure': 'pain during walking, NRS 0-10', 'timeFrame': 'at 24 hours postoperatively', 'description': 'NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)'}], 'secondaryOutcomes': [{'measure': 'pain at rest, NRS 0-10', 'timeFrame': 'preoperatively, postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours, seventh postoperative day', 'description': 'NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)'}, {'measure': 'consumption of intravenous oxycodone, milligrams/kilogram body weight', 'timeFrame': 'postoperatively: at 2 hours, at 8 hours, at 24 hours, at 48 hours', 'description': 'cumulative dose of oxycodone administered with a PCA (patient-controlled analgesia)-device'}, {'measure': 'nausea, NRS 0-10', 'timeFrame': 'postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours', 'description': 'NRS (numerical rating scale: 0=no nausea, 10 = worst possible nausea)'}, {'measure': 'general wellbeing, NRS 0-10', 'timeFrame': 'postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours', 'description': 'NRS (numerical rating scale: 0=worst, 10 = best)'}, {'measure': 'quality of sleep, NRS 0-10', 'timeFrame': 'postoperatively at 24 hours, at 48 hours', 'description': 'NRS (numerical rating scale: 0=worst, 10 = best)'}, {'measure': 'time to achieve discharge criteria, hours', 'timeFrame': 'postoperatively: at 24 hours, at 48 hours, at 72 hours, at 96 hours', 'description': 'time to achieve discharge criteria, hours'}, {'measure': 'pain during walking, NRS 0-10', 'timeFrame': 'preoperatively, postoperatively: at 8 hours, at 48 hours, seventh postoperative day', 'description': 'NRS (numerical rating scale: 0=no pain, 10 = worst possible pain)'}, {'measure': 'vomiting, yes/no', 'timeFrame': 'postoperatively: at 2 hours, at 8 hours,at 24 hours, at 32 hours, at 48 hours', 'description': 'vomiting, yes/no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arthroplasty', 'Knee Replacement', 'Pain, Postoperative', 'Glucocorticoids', 'Dexamethasone'], 'conditions': ['Arthroplasty, Knee Replacement', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '23581549', 'type': 'BACKGROUND', 'citation': 'Lunn TH, Kehlet H. Perioperative glucocorticoids in hip and knee surgery - benefit vs. harm? A review of randomized clinical trials. Acta Anaesthesiol Scand. 2013 Aug;57(7):823-34. doi: 10.1111/aas.12115. Epub 2013 Apr 15.'}, {'pmid': '23937923', 'type': 'BACKGROUND', 'citation': 'Backes JR, Bentley JC, Politi JR, Chambers BT. Dexamethasone reduces length of hospitalization and improves postoperative pain and nausea after total joint arthroplasty: a prospective, randomized controlled trial. J Arthroplasty. 2013 Sep;28(8 Suppl):11-7. doi: 10.1016/j.arth.2013.05.041. Epub 2013 Aug 9.'}, {'pmid': '21799397', 'type': 'BACKGROUND', 'citation': 'De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.'}, {'pmid': '15504179', 'type': 'BACKGROUND', 'citation': 'Gilron I. Corticosteroids in postoperative pain management: future research directions for a multifaceted therapy. Acta Anaesthesiol Scand. 2004 Nov;48(10):1221-2. doi: 10.1111/j.1399-6576.2004.00581.x. No abstract available.'}, {'pmid': '12437261', 'type': 'BACKGROUND', 'citation': 'Holte K, Kehlet H. Perioperative single-dose glucocorticoid administration: pathophysiologic effects and clinical implications. J Am Coll Surg. 2002 Nov;195(5):694-712. doi: 10.1016/s1072-7515(02)01491-6. No abstract available.'}, {'pmid': '22066560', 'type': 'BACKGROUND', 'citation': 'Husted H, Lunn TH, Troelsen A, Gaarn-Larsen L, Kristensen BB, Kehlet H. Why still in hospital after fast-track hip and knee arthroplasty? Acta Orthop. 2011 Dec;82(6):679-84. doi: 10.3109/17453674.2011.636682. Epub 2011 Nov 9.'}, {'pmid': '17850557', 'type': 'BACKGROUND', 'citation': 'Kehlet H. Glucocorticoids for peri-operative analgesia: how far are we from general recommendations? Acta Anaesthesiol Scand. 2007 Oct;51(9):1133-5. doi: 10.1111/j.1399-6576.2007.01459.x. No abstract available.'}, {'pmid': '23645340', 'type': 'BACKGROUND', 'citation': 'Koh IJ, Chang CB, Lee JH, Jeon YT, Kim TK. Preemptive low-dose dexamethasone reduces postoperative emesis and pain after TKA: a randomized controlled study. Clin Orthop Relat Res. 2013 Sep;471(9):3010-20. doi: 10.1007/s11999-013-3032-5. Epub 2013 May 4.'}, {'pmid': '21131371', 'type': 'BACKGROUND', 'citation': 'Lunn TH, Kristensen BB, Andersen LO, Husted H, Otte KS, Gaarn-Larsen L, Kehlet H. Effect of high-dose preoperative methylprednisolone on pain and recovery after total knee arthroplasty: a randomized, placebo-controlled trial. Br J Anaesth. 2011 Feb;106(2):230-8. doi: 10.1093/bja/aeq333. Epub 2010 Dec 3.'}, {'pmid': '22760385', 'type': 'BACKGROUND', 'citation': 'Richards JE, Kauffmann RM, Zuckerman SL, Obremskey WT, May AK. Relationship of hyperglycemia and surgical-site infection in orthopaedic surgery. J Bone Joint Surg Am. 2012 Jul 3;94(13):1181-6. doi: 10.2106/JBJS.K.00193.'}, {'pmid': '15504180', 'type': 'BACKGROUND', 'citation': 'Romundstad L, Breivik H, Niemi G, Helle A, Stubhaug A. Methylprednisolone intravenously 1 day after surgery has sustained analgesic and opioid-sparing effects. Acta Anaesthesiol Scand. 2004 Nov;48(10):1223-31. doi: 10.1111/j.1399-6576.2004.00480.x.'}, {'pmid': '16757774', 'type': 'BACKGROUND', 'citation': 'Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.'}, {'pmid': '11085349', 'type': 'BACKGROUND', 'citation': 'Sauerland S, Nagelschmidt M, Mallmann P, Neugebauer EA. Risks and benefits of preoperative high dose methylprednisolone in surgical patients: a systematic review. Drug Saf. 2000 Nov;23(5):449-61. doi: 10.2165/00002018-200023050-00007.'}, {'pmid': '23220857', 'type': 'BACKGROUND', 'citation': 'Waldron NH, Jones CA, Gan TJ, Allen TK, Habib AS. Impact of perioperative dexamethasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth. 2013 Feb;110(2):191-200. doi: 10.1093/bja/aes431. Epub 2012 Dec 5.'}, {'pmid': '17294992', 'type': 'BACKGROUND', 'citation': 'Smith C, Erasmus PJ, Myburgh KH. Endocrine and immune effects of dexamethasone in unilateral total knee replacement. J Int Med Res. 2006 Nov-Dec;34(6):603-11. doi: 10.1177/147323000603400605.'}, {'pmid': '18349202', 'type': 'BACKGROUND', 'citation': 'Kardash KJ, Sarrazin F, Tessler MJ, Velly AM. Single-dose dexamethasone reduces dynamic pain after total hip arthroplasty. Anesth Analg. 2008 Apr;106(4):1253-7, table of contents. doi: 10.1213/ANE.0b013e318164f319.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery.', 'detailedDescription': 'The purpose of this study is to examine, if a single-dose of dexamethasone given during the operation, alleviates pain after knee replacement surgery. This is also a dose-finding study comparing two doses of dexamethasone.\n\nTotal knee arthroplasty causes considerable pain. Multimodal analgesia and peripheral nerve blocks are used for treatment of pain. Some studies suggest that glucocorticoids alleviate postoperative pain. The optimal dose of dexamethasone in treatment of postoperative pain is not known. Studies on this subject in patients with total knee replacement are sparse. Potential side-effects of dexamethasone (hyperglycemia, wound infection) need to be studied.\n\nPatients coming for primary knee replacement surgery are enrolled. The patients in each study group receive multimodal therapy for postoperative pain: etoricoxib, paracetamol, gabapentin and oxycodone. A single dose of intravenous dexamethasone (0,15 mg/kg or 0,25 mg/kg) or a placebo (saline) is administered to the patient during the operation. The effect of dexamethasone on postoperative pain is observed: main outcome is dynamic pain at 24 h postoperatively. The extent of inflammatory reaction is measured (CRP). Serial blood glucose measurements are done.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary total knee replacement surgery\n* ASA (american society of anesthesiologists) class 1-3\n\nExclusion Criteria:\n\n* severe coronary artery disease, heart failure, kidney failure\n* insulin-dependent DM (diabetes mellitus), poorly controlled type II DM\n* gastric/duodenal ulcer\n* allergy/contra-indication for any drug used in the study\n* corticosteroid use during last 3 months\n* preoperative use of opioid drugs (excl. codeine, tramadol)\n* neuropathy/sensory impairment of lower limbs\n* lack of co-operation, e.g. inability to use a PCA (patient controlled analgesia)-device'}, 'identificationModule': {'nctId': 'NCT03034733', 'briefTitle': 'The Effect of Dexamethasone on Pain After Total Knee Replacement Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'The Effect of Intravenous Single-dose Dexamethasone on Pain After Total Knee Replacement Surgery', 'orgStudyIdInfo': {'id': 'Polvitepdexa 24052016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexamethasone 0,15 mg/kg', 'description': 'single-dose intravenous dexamethasone 0,15 mg/kg, intraoperative', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'dexamethasone 0,25 mg/kg', 'description': 'single-dose intravenous dexamethasone 0,25 mg/kg, intraoperative', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sodium Chloride, (24)NaCl 0,9%', 'description': 'single-dose intravenous saline, intraoperative', 'interventionNames': ['Drug: Sodium Chloride, (24)NaCl 0,9%']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Oradexon'], 'description': 'intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg', 'armGroupLabels': ['dexamethasone 0,15 mg/kg', 'dexamethasone 0,25 mg/kg']}, {'name': 'Sodium Chloride, (24)NaCl 0,9%', 'type': 'DRUG', 'otherNames': ['saline'], 'description': 'intravenous placebo', 'armGroupLabels': ['Sodium Chloride, (24)NaCl 0,9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90029', 'city': 'Oulu', 'state': 'OYS', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Matti Kyllönen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oulu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}