Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2026-01-05 @ 5:11 PM
Study NCT ID:
NCT02125903
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-23', 'studyFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2014-04-28', 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed-Up and Go-test for mobility evaluation', 'timeFrame': 'third postoperative day', 'description': 'The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.'}], 'secondaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': '6, 24, 48, 72 hours postoperative', 'description': 'Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain'}, {'measure': 'Quadriceps strength', 'timeFrame': '6, 24, 28, 72 hours postoperative', 'description': 'Numeric Scale (0-5)'}, {'measure': 'Ropivacaine consumption (each catheter)', 'timeFrame': '24, 48, 72 hours postoperative', 'description': 'Measurement of the total amount'}, {'measure': 'CAS (Cumulated Ambulation Score)', 'timeFrame': '24,48,72 hours postoperative', 'description': 'Cumulated Ambulation Score is calculated with routine data. Measurement for ambulation ability'}, {'measure': 'Mobility Score (MoSc)', 'timeFrame': '24,48,72 hours postoperative', 'description': 'Is calculated with routine data. Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)'}, {'measure': 'Analgesic regimen', 'timeFrame': 'preop and 0, 6 , 24, 48, 48 hours postoperative', 'description': 'Documentation of analgesic prescriptions and rescue medications during postoperative course'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty', 'Total Knee Replacement', 'Femoral Nerve Block', 'Adductor Canal Block']}, 'descriptionModule': {'briefSummary': 'The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.\n\nAn alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.\n\nThis prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).\n\nWe expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with knee replacement therapy and general anaesthesia\n* informed consent\n* preoperative "timed up and go" test performable\n\nExclusion Criteria:\n\n* emergency patients\n* BMI \\> 40 kg/m2\n* American Society of Anaesthesiologists physical status (ASA) 4-5\n* severe chronic obstructive pulmonary disease (COPD)\n* rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson\n* nerve injury of lumbosacral plexus\n* coagulopathy with bleeding tendency\n* not capable of speaking or understanding german or english'}, 'identificationModule': {'nctId': 'NCT02125903', 'briefTitle': 'Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Philipps University Marburg'}, 'officialTitle': 'Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia', 'orgStudyIdInfo': {'id': 'AZ 06/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Adductor Canal Block (CACB)', 'description': 'Continuous Adductor Canal block performed with:\n\nloading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h\n\nProcedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous Femoral Nerve Block (CFNB)', 'description': 'Continuous Femoral Nerve Block performed with:\n\nloading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h\n\nProcedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine', 'interventionNames': ['Drug: Ropivacaine']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)', 'armGroupLabels': ['Continuous Adductor Canal Block (CACB)', 'Continuous Femoral Nerve Block (CFNB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35037', 'city': 'Marburg', 'country': 'Germany', 'facility': 'University of Marburg Department of Anaesthesia And Intensive Care Medicine', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}], 'overallOfficials': [{'name': 'Karolin Piechowiak, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept. of Anesthesia And Intensiv Care Medicine University of Marburg'}, {'name': 'Thorsten Steinfeldt, Prof Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept. of Anesthesia And Intensive Care Medicine University of Marburg'}, {'name': 'Thomas Wiesmann, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept. of Anesthesia And Intensive Care Medicine University of Marburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philipps University Marburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Karolin Piechowiak', 'investigatorFullName': 'Karolin Piechowiak', 'investigatorAffiliation': 'Philipps University Marburg'}}}}