Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT06233604
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After 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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'first need of opiate', 'timeFrame': '48 hours after surgery', 'description': 'Time after surgery when the patient needs opiate for the first time'}], 'secondaryOutcomes': [{'measure': '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': 'NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '8 hours after surgery', 'description': 'NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '12 hours after surgery', 'description': 'NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '16 hours after surgery', 'description': 'NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '20 hours after surgery', 'description': 'NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': '24 hours after surgery', 'description': 'NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)'}, {'measure': 'NLR', 'timeFrame': '48 hours after surgery', 'description': 'Neutrophil-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '48 hours after surgery', 'description': 'Platelet-to-lymphocyte ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Osteoarthritis', 'Hip Arthropathy', 'Hip Pain Chronic']}, 'descriptionModule': {'briefSummary': 'Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for hip arthroplasty', 'detailedDescription': 'This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for spine surgery.\n\nAfter spine surgery, patients need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.\n\nThe safety of local anaesthesia is essential due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.\n\nThere is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use have been compared in adults. However, there is a massive lack of research regarding spine surgery and the Erector Spinae Plane Block.\n\nIn this study, investigators compare perineural Dexamethasone and Dexmedetomidine.\n\nThe investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing primary hip arthroplasty\n* aged \\>18 years and \\<100 years\n* ASA physical status 1, 2 or 3.\n\nExclusion Criteria:\n\n* if they refused to participate,\n* had a history of opioid abuse,\n* had an infection of the site of needle puncture,\n* were less than 18 years of age,\n* were postponed as having ASA 4 or 5,\n* had an allergy to any of the drugs used in the study,\n* renal failure (estimated glomerular filtration rate \\<15ml/min/1.73m2),\n* liver failure,\n* known or suspected coagulopathy,\n* pre-existing anatomical or neurological disorders in the lower extremities,\n* intellectual disability with problems in pain evaluation,\n* severe psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT06233604', 'briefTitle': 'Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty', 'orgStudyIdInfo': {'id': '2/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.2% ropivacaine for erector spinae plane block', 'interventionNames': ['Drug: 0.9%sodium chloride']}, {'type': 'EXPERIMENTAL', 'label': 'Dexamethasone', 'description': '0.2% ropivacaine + 4mg Dexamethasone for erector spinae plane block', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': '0.2% ropivacaine + 50ug Dexmedetomidine for erector spinae plane block', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': '0.9%sodium chloride', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'unilateral administration of 20ml of 0,2% ropivacaine + 2ml 0.9% sodium chloride for the erector spine plane block', 'armGroupLabels': ['Placebo']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'unilateral administration of 20ml of 0,2% ropivacaine with 4mg Dexamethasone for the erector spine plane block', 'armGroupLabels': ['Dexamethasone']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'unilateral administration of 20ml of 0,2% ropivacaine with 50ug Dexmedetomidine for the erector spine plane block', 'armGroupLabels': ['Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-701', 'city': 'Poznan', 'state': 'Poznań', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Malgorzata Domagalska, Ph.D.', 'role': 'CONTACT', 'email': 'm.domagalska@icloud.com', 'phone': '608762068'}], 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Malgorzata Domagalska, Ph.D.', 'role': 'CONTACT', 'email': 'm.domagalska@icloud.com', 'phone': '+48 61 873 83 03'}, {'name': 'Malgorzata Domagalska, Ph.D.', 'role': 'CONTACT', 'email': 'm.domagalska@icloud.com', 'phone': '608762068'}], 'overallOfficials': [{'name': 'Katarzyna Wieczorowska-Tobis, Prof.dr hab.', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznań University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}