Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:44 AM
Study NCT ID:
NCT03763760
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2018-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}, {'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'}], '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'], 'maskingDescription': 'All intervention drugs will be blinded by a nurse who is not a participant in the study or in the treatment of the patient in any way.\n\nThe Patient, the administrator of the drug(nurse or doctor), the assessor, the investigator and the care team will all be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized double blinded controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-29', 'studyFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward.', 'timeFrame': '7 days.', 'description': 'An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center.\n\nThe questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications.\n\nThe outcome assesment will be descriptive.'}], 'primaryOutcomes': [{'measure': 'Postoperative pain after 24 hours: VAS', 'timeFrame': '24 hours', 'description': 'The amount of patients with moderate postoperative pain in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.\n\nPain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS \\>30 mm.'}], 'secondaryOutcomes': [{'measure': 'Postoperative opioid usage', 'timeFrame': '7 days', 'description': 'The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.'}, {'measure': 'Postoperative antiemetics usage', 'timeFrame': '7 days', 'description': 'The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.'}, {'measure': 'The inflammatory response expressed by C-reactive protein(CRP).', 'timeFrame': '2 days', 'description': 'The inflammatory response is monitored by the blood-sample c-reactive protein(CRP) and analyzed to se the possible attenuation of the response because of dexamethasone.'}, {'measure': 'Postoperative pain summarized in the first 7 days', 'timeFrame': '7 days', 'description': 'Pain summarized over the first 7 days after surgery, assessed by a summation of the Visual Analog Scale(VAS)-scores in the first 7 days as noted in the pain diary filed in by the participants.\n\nPain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain one can imagine. Moderate pain is considered a VAS \\>30 mm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip Arthroplasty', 'Hip Replacement', 'Perioperative Medicine'], 'conditions': ['Postoperative Pain', 'Postoperative Nausea and Vomiting', 'Hip Osteoarthritis', 'Perioperative/Postoperative Complications', 'Surgery', 'Opioid Use', 'Catastrophizing Pain', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '37166257', 'type': 'DERIVED', 'citation': 'Nielsen NI, Kehlet H, Gromov K, Troelsen A, Husted H, Varnum C, Kjaersgaard-Andersen P, Rasmussen LE, Pleckaitiene L, Foss NB. High dose dexamethasone in high pain responders undergoing total hip arthroplasty: A randomized controlled trial. Eur J Anaesthesiol. 2023 Oct 1;40(10):737-746. doi: 10.1097/EJA.0000000000001853. Epub 2023 May 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior to surgery in the setting of Fast-Track Hip-surgery with Arthroplasty in a group of expected High Pain Responders and the effect on postoperative pain and postoperative inflammation.', 'detailedDescription': "This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.\n\nThe investigators compare the already used dose(medium dose) with a new high dose(HD) steroid given as an intravenous bolus after the spinal anaesthesia has been given, but before the surgery starts.\n\nThe hypothesis is that by attenuating the inflammatory response to the surgery itself by the steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon ambulation 24 hours after unilateral Hip Arthroplasty.\n\nPatients referred to Unilateral Total Hip Arthroplasty because of Hip-osteoarthritis at Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are screened and offered inclusion in the study.\n\nThe two groups will be randomized and double blinded. One group will be treated, as the current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).\n\nThe other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg bodyweight).\n\nThe patients will be monitored the first 7 days after surgery, during the admission to the hospital, and by a Pain-diary in the patients own home.\n\nBlood tests will be taken preoperatively and postoperatively to determine the effect of the highdose steroid on the inflammatory response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 90.\n* Booked for unilateral Hip-arthroplasty.\n* Is able to take part in the investigation(selfreported pain and nausea/vomiting)\n* Understands Danish or English, or has a translator available.\n* Signed written consent.\n* A daily use of 30 mg or more of morphine or morphine equivalents .\n* A pain catastrophizing scale(PCS) score of \\>20.\n\nExclusion Criteria:\n\n* Insulin-dependent diabetes melitus.\n* Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart from inhaled glucocorticoids).\n* Pregnancy/Breastfeeding\n* Allergies for the investigational drug.\n* A history of schizophrenia or bipolar diseases, or patients with permanent use of antipsychotic medication.'}, 'identificationModule': {'nctId': 'NCT03763760', 'briefTitle': 'High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'High-Dose Steroids in High Pain Responders Undergoing Total Hip-arthroplasty: A Randomized Double Blinded Controlled Trial', 'orgStudyIdInfo': {'id': 'NBF_HK_03_2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose Dexamethasone', 'description': 'An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medium dose Dexamethasone', 'description': 'An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery.', 'interventionNames': ['Drug: Dexamethasone']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Dexa-ratiopharm'], 'description': 'An intravenous bolus dose of dexamethasone given prior to surgery.', 'armGroupLabels': ['High dose Dexamethasone', 'Medium dose Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital, Capital Region of Denmark.', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Vejle Sygehus', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Nicolai Bang Foss, Dr.med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Niklas Ingemann Nielsen', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}