Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 10:41 AM
Study NCT ID:
NCT04432259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2020-06-16
First Post:
2020-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States'], 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-12', 'mcpReleaseN': 1, 'releaseDate': '2024-02-16'}], 'estimatedResultsFirstSubmitDate': '2024-02-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'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': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-12', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '3 weeks following surgery', 'description': 'Postoperative pain will be collected via visual analog scores'}, {'measure': 'Postoperative Nausea', 'timeFrame': '3 weeks following surgery', 'description': 'Postoperative Nausea will be collected via visual analog scores'}, {'measure': 'Opioid Consumption', 'timeFrame': '6 months', 'description': 'Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded'}, {'measure': 'Antiemetic Consumption', 'timeFrame': '6 months'}, {'measure': 'Episodes of Nausea', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '6 months', 'description': 'Incidence of surgical site infection, acute prosthetic joint infection'}, {'measure': 'Patient-reported outcome scores (PROMS)', 'timeFrame': '6 months'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS)', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis Knee', 'Postoperative Nausea', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.', 'detailedDescription': 'Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients age 18 and older who will be undergoing joint replacement\n\nExclusion Criteria:\n\n* Patients with uncontrolled diabetes ( HbA1C, \\>7.5%), impaired hepatic function (Child class, \\>B), impaired renal failure (Glomerular filtration rate \\<60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT04432259', 'briefTitle': 'Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '13565'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm B: Oral Dexamethasone', 'description': 'Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm A: Placebo', 'description': 'Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': '4 mg bid for 4 days', 'armGroupLabels': ['Arm B: Oral Dexamethasone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral placebo', 'armGroupLabels': ['Arm A: Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jonathan Shaw, M.D.', 'role': 'CONTACT', 'email': 'jshaw5@hfhs.org', 'phone': '414-405-8544'}], 'overallOfficials': [{'name': 'Jason Davis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Surgeon', 'investigatorFullName': 'Jonathan H. Shaw', 'investigatorAffiliation': 'Henry Ford Health System'}}}}