Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT06470334
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2024-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone With Ropivacaine for PENG Block in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], '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': '2024-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', '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': '24 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'glucose', 'timeFrame': '48 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'NLR', 'timeFrame': '12 hours after surgery', 'description': 'neutrophile-to-lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '24 hours after surgery', 'description': 'neutrophile-to-lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '48 hours after surgery', 'description': 'neutrophile-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '12 hours after surgery', 'description': 'platelet-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '24 hours after surgery', 'description': 'platelet-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '48 hours after surgery', 'description': 'platelet-to-lymphocyte ratio'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Osteoarthritis', 'Hip Pain Chronic', 'Hip Arthritis']}, 'descriptionModule': {'briefSummary': 'Does adding Dexamethasone to the Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty reduce the dose of ropivacaine?', 'detailedDescription': 'Hip 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': 'NCT06470334', 'briefTitle': 'Dexamethasone With Ropivacaine for PENG Block in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Pericapsular Nerve Group Block With 20 ml 0.2% Ropivacaine vs 10ml 0.2% Ropivacaine and Dexamethasone in Total Hip Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '8/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine', 'description': 'Ultrasound-guided PENG block - 20ml 0,2% ropivacaine', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine + Dexamethasone', 'description': 'Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg Dexamethasone', 'interventionNames': ['Drug: Ropivacaine+Dexamethasone']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Pericapsular Nerve Group Block'], 'description': 'Ultrasound-guided PENG block - 20ml 0,2% ropivacaine', 'armGroupLabels': ['Ropivacaine']}, {'name': 'Ropivacaine+Dexamethasone', 'type': 'DRUG', 'otherNames': ['Pericapsular Nerve Group Block'], 'description': 'Ultrasound-guided PENG block - 10ml 0,2% ropivacaine + 4mg 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': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Following study completion', 'ipdSharing': 'YES', 'description': 'Individual participant data will be available following study completion', 'accessCriteria': 'Eligible researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}