Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06302218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ESPB vs iPACK+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'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, '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': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': '48 hours after surgery', 'description': 'Total opiate consumption after surgery'}], 'secondaryOutcomes': [{'measure': 'Time to first rescue opiate analgesia', 'timeFrame': '48 hours after procedure', 'description': 'Time after surgery when the patient needs opiate for the first time'}, {'measure': 'Numerical Rating Scale [range 0:10]', 'timeFrame': 'Time Frame: 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': 'Time Frame: 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': 'Time Frame: 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': 'Time Frame: 16 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': 'Time Frame: 20 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': 'Time Frame: 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': 'Time Frame: 36 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': 'Time Frame: 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': 'Neutrophil-to-lymphocyte ratio', 'timeFrame': '24 hours after surgery', 'description': 'Neutrophil-to-lymphocyte ratio'}, {'measure': 'Neutrophil-to-lymphocyte ratio', 'timeFrame': '48 hours after surgery', 'description': 'Neutrophil-to-lymphocyte ratio'}, {'measure': 'Platelet-to-lymphocyte ratio', 'timeFrame': '24 hours after surgery', 'description': 'Platelet-to-lymphocyte ratio'}, {'measure': 'Platelet-to-lymphocyte ratio', 'timeFrame': '48 hours after surgery', 'description': 'Platelet-to-lymphocyte ratio'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the medical research council muscle strength rating'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Arthritis', 'Knee Arthropathy', 'Knee Osteoarthritis', 'Knee Pain Chronic', 'Knee Disease', 'Knee Rheumatism']}, 'descriptionModule': {'briefSummary': 'Effect of iPACK block with Adductor Canal Block and ESPB on pain management, and NLR and PLR following 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 surgery's induced stress response, opioid consumption, and opioid-related side effects.\n\nIn recent years, the influence of regional anesthesiology on reducing the inflammatory response after surgical procedures has been emphasised. However, very few studies have evaluated the effect of various methods of anaesthesia on the NLR and PLR.\n\nThis is the first study to investigate the effect of regional anaesthesia on the pain managementonse expres and stress respsed by the NLR and PLR in patients undergoing knee replacement surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ASA classification I-III, Aged 20-90 years, Who will be scheduled for knee arthroplasty under spinal anaesthesia.\n\nExclusion Criteria:\n\n* patients who have a history of bleeding diathesis,\n* take anticoagulant therapy,\n* have a History of chronic pain before surgery,\n* have Multiple trauma, cannot assess their pain (dementia),\n* have been operated on under general anaesthesia,\n* have an infection in the area and do not accept the procedure'}, 'identificationModule': {'nctId': 'NCT06302218', 'briefTitle': 'ESPB vs iPACK+ACB in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Erector Spinae Plane Block vs. iPACK Block With Adductor Canal Block for Pain Management in Patients Undergoing Total Knee Replacement', 'orgStudyIdInfo': {'id': '5/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iPACK + ACB', 'description': 'spinal anesthesia\n\n\\+ ultrasound guided iPACK (20ml 0,2% ropivacaine) with ACB (10ml 0.5% ropivacaine)', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erectro Spinae Plane Block', 'description': 'spinal anesthesia\n\n\\+ ultrasound guided ESPBk - 20ml 0,2% ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Only spinal anesthesia - No peripheral nerve block', 'interventionNames': ['Drug: control group']}], 'interventions': [{'name': 'Ropivacaine 0.2% Injectable Solution', 'type': 'DRUG', 'otherNames': ['iPACK + ACB'], 'description': 'iPACK block + Adductor Canal Block', 'armGroupLabels': ['iPACK + ACB']}, {'name': 'Ropivacaine 0.2% Injectable Solution', 'type': 'DRUG', 'otherNames': ['ESPB'], 'description': 'Erector Spinae Plane Block', 'armGroupLabels': ['Erectro Spinae Plane Block']}, {'name': 'control group', 'type': 'DRUG', 'otherNames': ['only spinal anesthesia'], 'description': 'only spinal anesthesia', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-701', 'city': 'Poznan', 'state': 'Poznań', 'country': 'Poland', 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Malgorzata Domagalska, Ph.D.', 'role': 'CONTACT', 'email': 'm.domagalska@ump.edu.pl', 'phone': '608762068'}, {'name': 'Małgorzata Domagalska, Ph.D.', 'role': 'CONTACT', 'email': 'm.domagalska@ump.edu.pl', 'phone': '61 873 83 03'}], 'overallOfficials': [{'name': 'Łukasz Łapaj, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznań University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 month after study completion', 'ipdSharing': 'YES', 'accessCriteria': 'from the corresponding author on the resonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}