Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT06470204
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2024-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexamethasone for iPACK Block With ACB in Total Knee Arthroplasty
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': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, '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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first rescue opioid analgesia', 'timeFrame': '48 hours after surgery', 'description': 'Time after surgery when the patient needs opiate for the first time'}], 'secondaryOutcomes': [{'measure': 'Total Opioid Consumption', 'timeFrame': '48 hours after surgery', 'description': 'Total opiate consumption after surgery'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '4 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '8 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '12 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '24 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '48 hours after surgery', 'description': 'Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '4 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '8 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '12 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '24 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '48 hours after surgery', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}, {'measure': 'Nerve damage [range 0-4]', 'timeFrame': '12 hours after surgery', 'description': 'Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)'}, {'measure': 'Nerve damage [range 0-4]', 'timeFrame': '24 hours after surgery', 'description': 'Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)'}, {'measure': 'Nerve damage [range 0-4]', 'timeFrame': '48 hours after surgery', 'description': 'Nerve damage assesment will be performed using the nerve damage score (N0- no nerve damage; N1- minor - sensory paresthesia; N2- major -complete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome)'}, {'measure': 'glucose', 'timeFrame': '12 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'glucose', 'timeFrame': '24 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'glucose', 'timeFrame': '48 hours after surgery', 'description': 'blood glucose level'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Knee Pain Chronic', 'Knee Arthritis']}, 'descriptionModule': {'briefSummary': 'Effect of adding Dexamethasone to Infiltration between the Popliteal Artery and Capsule of the Knee Block with ACB in Patients undergoing Total Knee Arthroplasty', 'detailedDescription': 'Knee arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for total hip arthroplasty\n* patients aged \\>65 and \\<100 years\n* patients able to provide informed consent\n* patients able to reliably report symptoms to the research team\n\nExclusion Criteria:\n\n* inability to provide first-party consent due to cognitive impairment or a language barrier'}, 'identificationModule': {'nctId': 'NCT06470204', 'briefTitle': 'Dexamethasone for iPACK Block With ACB in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Infiltration Between the Popliteal Artery and Capsule of the Knee Block With Adductor Canal Block With Ropivacaine vs Ropivacaine and Dexamethasone in Total Knee Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '7/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine', 'description': 'iPACK Block + ACB with Ropivacaine', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine + Dexamethasone', 'description': 'iPACK Block + ACB with Ropivacaine + Dexamethasone', 'interventionNames': ['Drug: Ropivacaine+Dexamethasone']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2ml 0.9% NaCl)', 'armGroupLabels': ['Ropivacaine']}, {'name': 'Ropivacaine+Dexamethasone', 'type': 'DRUG', 'description': 'Ultrasound-guided iPACK block + ACB - 2 x (20ml 0,2% ropivacaine + 2mg Dexamethasone)', 'armGroupLabels': ['Ropivacaine + Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-701', 'city': 'Poznan', 'state': 'Poznań', 'country': 'Poland', 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznań University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Following the trial completion', 'ipdSharing': 'YES', 'description': 'Individual participant data will be available to eligible researchers following the trial completion', 'accessCriteria': 'Elligible researcher'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}