Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT06339151
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2024-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing Single Dose and Multiple Dose of Dexamethasone Post 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011184', 'term': 'Postoperative Period'}], 'ancestors': [{'id': 'D059035', 'term': 'Perioperative Period'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-05', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain at rest and motion', 'timeFrame': 'At 6 hour, 12 hour, 18 hour, 24 hour, 30 hour, 36 hour, 42 hour, 48 hour, 54 hour, 60 hour, 66 hour and 72 hour after surgery', 'description': 'Using visual analog scale 0-10 (0 means best, 10 means worst)'}], 'secondaryOutcomes': [{'measure': 'Nausea and vomiting', 'timeFrame': 'At 24 hour, 48 hour and 72 hour after surgery', 'description': 'Using visual analog scale 0-10 (0 means best, 10 means worst)'}, {'measure': 'Morphine consumption', 'timeFrame': 'At 24 hour, 48 hour and 72 hour after surgery', 'description': 'Total milligrams use of morphine postoperative (record in mg)'}, {'measure': 'Blood sugar level', 'timeFrame': 'At 24 hour and 48 hour after surgery', 'description': 'record in mg/dL'}, {'measure': 'CRP level', 'timeFrame': 'At 24 hour and 48 hour after surgery', 'description': 'record in mg/dL'}, {'measure': 'Range of motion', 'timeFrame': 'At 24 hour and 48 hour after surgery', 'description': 'Using long arm goniometer (record in degrees)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 1 week', 'description': 'Number of days the patient stays for surgery'}, {'measure': 'Complication', 'timeFrame': 'up to 6 months', 'description': 'Surgical site infection, deep infection or wound complication'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'dexamethasone'], 'conditions': ['Osteo Arthritis Knee', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '30033064', 'type': 'BACKGROUND', 'citation': 'Xu H, Zhang S, Xie J, Lei Y, Cao G, Pei F. Multiple Doses of Perioperative Dexamethasone Further Improve Clinical Outcomes After Total Knee Arthroplasty: A Prospective, Randomized, Controlled Study. J Arthroplasty. 2018 Nov;33(11):3448-3454. doi: 10.1016/j.arth.2018.06.031. Epub 2018 Jul 4.'}]}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement.\n\nThe main question\\[s\\] it aims to answer \\[is/are\\]:\n\nDoes 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement?\n\nResearchers will compare double dose of dexamethasone group to see if \\[insert effects\\].\n\nParticipants will \\[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\\].", 'detailedDescription': '1. Randomized patients into 3 groups\n\n * Group 1: Patients received only Dexamethasone 0.15 mg/kg IV before surgery.\n * Group 2: Patients received Dexamethasone 0.15 mg/kg IV before surgery and Dexamethasone 0.15 mg/kg at 12 hours after surgery.\n * Group 3: Patients received Dexamethasone 0.15 mg/kg before surgery along and Dexamethasone 0.15 mg/kg at 24 hours after surgery.\n2. Preemptive analgesia Alprazolam 0.5 mg. 1 tablet, Pregabalin 75 mg. 1 tablet before bedtime Celecoxib 400 mg. 1 tablet, Omeprazole 20 mg 1 mg tablet, Paracetamol 500 mg 2 tablets and 1 Ondansetron 4 mg 1 tablet at 1 hour before surgery.\n3. The researcher will give an injection. Dexamethasone 0.15 mg/kg injection form together with Cefazolin 1 gm injection form by the anesthesiologist 30 minutes before surgery.\n4. Spinal Anesthesia by an anesthesiologist before surgery The anesthetic component consists of 0.5% Bupivacaine 15 mg, which does not contain morphine, along with local anesthesia in the thigh area (Adductor canal block) with a mixture of 0.5% Bupivacaine 15 mg.\n5. All patients will undergo knee replacement surgery in the same manner\n6. Periarticular cocktail injection The drug contains Tranexamic acid 10 mg/kg, Morphine 5 mg, Adrenaline 0.5 mg, 5% Bupivacaine 200 mg (Marcaine 1 amp), Ketorolac 30 mg (1 amp) mixed with saline (Normal saline) until 75 ml of area is obtained. The injection site is placed around the knee joint and knee capsule.\n7. After surgery, the patient will stay in the recovery room for 2 hours to take care of their symptoms.\n8. Pain relievers after surgery include\n\n * Parecoxib (Dynastat) 40 mg injection every 12 hours for the first 2 days after knee replacement surgery, then change the medicine to Celecoxib 400 mg. 1 tablet after breakfast\n * Paracetamol 500 mg. 2 tablets every 6 hours for the first 2 days after knee replacement surgery. After that, give Paracetamol 500 mg. 2 tablets pro for pain every 6 hours\n * Pregabalin 75 mg. 1 tablet po hs\n * Morphine 3 mg injection every 4 hours for patients with a pain score greater than 4 points (VAS-P score ≥4)\n * Ondansetron 4 mg IV prn for nausea and vomitting every 6 hours\n * Alprazolam 0.5 mg 1 tab po hs\n * Cefazolin 1 gm IV every 6 hours for the first 24 hours after surgery\n9. Group 2 patients will receive Dexamethasone 0.15 mg/kg as an injection after surgery at 12 hours, and patients in Group 3 will receive Dexamethasone 0.15 mg/kg as injection at 24 hours after surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of primary osteoarthritis of knee joint\n* Undergo unilateral primary total knee replacement\n* Age between 50-85 years old\n\nExclusion Criteria:\n\n* Allergy to dexamethasone\n* History of long term corticosteroid used\n* New York heart association (NYHA) class \\> II\n* Type 2 Diabetes mellitus that had HbA1c \\> 7 % or FBS \\> 200 mg/dl\n* Chronic kidney disease \\> stage III or eGFR \\< 60\n* Cirrhosis Child class B or C\n* Cannot use pain controlled as protocol\n* History of previous knee surgery\n* History of previous septic arthritis at knee joint'}, 'identificationModule': {'nctId': 'NCT06339151', 'briefTitle': 'Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University Hospital'}, 'officialTitle': 'Efficacy of Intravenous Dexamethasone Injection Given 12 and 24 Hours for Pain After Total Knee Arthroplasty: A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'TUH multiple dexamethasone TKA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery.\n\nPostoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Normal saline solution injection', 'interventionNames': ['Drug: Dexamethasone before surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery.\n\nPostoperative 12 hr - Dexamethasone 0.15 mg/kg IV at 12 hours post operation Postoperative 24 hr - Normal saline solution injection', 'interventionNames': ['Drug: Dexamethasone before and 12 hours after surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'Preoperative - Dexamethasone 0.15 mg/kg injection by the anesthesiologist 30 minutes before surgery.\n\nPostoperative 12 hr - Normal saline solution injection Postoperative 24 hr - Dexamethasone 0.15 mg/kg IV at 24 hours post operation', 'interventionNames': ['Drug: Dexamethasone before and 24 hours after surgery']}], 'interventions': [{'name': 'Dexamethasone before surgery', 'type': 'DRUG', 'description': 'Dexamethasone 0.15 mg/kg IV before surgery', 'armGroupLabels': ['Group 1']}, {'name': 'Dexamethasone before and 12 hours after surgery', 'type': 'DRUG', 'description': 'Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 12 hours post operation', 'armGroupLabels': ['Group 2']}, {'name': 'Dexamethasone before and 24 hours after surgery', 'type': 'DRUG', 'description': 'Dexamethasone 0.15 mg/kg IV before surgery Dexamethasone 0.15 mg/kg IV at 24 hours post operation', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12120', 'city': 'Khlong Luang', 'state': 'Changwat Pathum Thani', 'country': 'Thailand', 'facility': 'Thammasat University Hospital', 'geoPoint': {'lat': 14.06467, 'lon': 100.64578}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Yot Tanariyakul', 'investigatorAffiliation': 'Thammasat University Hospital'}}}}