Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02082067
Status:
WITHDRAWN
Last Update Posted:
2016-08-09
First Post:
2014-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-08', 'studyFirstSubmitDate': '2014-02-28', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Up and Go test', 'timeFrame': '5th postoperative day', 'description': 'Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair'}], 'secondaryOutcomes': [{'measure': 'VAS score', 'timeFrame': 'up to POD5', 'description': 'Evaluation of VAS static and VAS dynamic during hospital stay'}, {'measure': 'Morphine request', 'timeFrame': 'up to POD5', 'description': 'Opioids consumption will be recorded throughout postoperative period'}, {'measure': 'Range of motion', 'timeFrame': '5th postoperative day', 'description': 'Physiotherapist measures the maximum active/passive range of motion'}, {'measure': 'Falling risk', 'timeFrame': '5th postoperative day', 'description': 'Evaluation of falling risk with Berg Balance Scale'}, {'measure': 'Quadriceps strength', 'timeFrame': '5th postoperative day', 'description': 'evaluate muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing total knee arthroplasty\n\nExclusion Criteria:\n\n* diabetes\n* neurological disorders\n* coagulation disorders\n* rheumatoid arthritis\n* chronic opioids therapy\n* allergy to local anesthetic'}, 'identificationModule': {'nctId': 'NCT02082067', 'briefTitle': 'Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'ASST Gaetano Pini-CTO'}, 'officialTitle': 'Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block', 'orgStudyIdInfo': {'id': 'IOGPGC05-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adductor canal', 'description': 'All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.', 'interventionNames': ['Procedure: Adductor canal', 'Procedure: Spinal Anesthesia', 'Procedure: Local anesthetic infusion', 'Procedure: Intravenous analgesia', 'Drug: Ropivacaine 0,75%', 'Drug: Levobupivacaine 0,5%', 'Drug: Levobupivacaine 0,125%', 'Drug: Ketorolac 30mg', 'Drug: Morphine', 'Device: stimulong sono, Pajunk, Germany']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral', 'description': 'All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.', 'interventionNames': ['Procedure: Femoral', 'Procedure: Spinal Anesthesia', 'Procedure: Local anesthetic infusion', 'Procedure: Intravenous analgesia', 'Drug: Ropivacaine 0,75%', 'Drug: Levobupivacaine 0,5%', 'Drug: Levobupivacaine 0,125%', 'Drug: Ketorolac 30mg', 'Drug: Morphine', 'Device: stimulong sono, Pajunk, Germany']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Controls', 'description': 'No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.', 'interventionNames': ['Procedure: Spinal Anesthesia', 'Procedure: Intravenous analgesia', 'Drug: Levobupivacaine 0,5%', 'Drug: Ketorolac 30mg', 'Drug: Morphine']}], 'interventions': [{'name': 'Adductor canal', 'type': 'PROCEDURE', 'description': 'Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.', 'armGroupLabels': ['Adductor canal']}, {'name': 'Femoral', 'type': 'PROCEDURE', 'description': 'Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.', 'armGroupLabels': ['Femoral']}, {'name': 'Spinal Anesthesia', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.', 'armGroupLabels': ['Adductor canal', 'Controls', 'Femoral']}, {'name': 'Local anesthetic infusion', 'type': 'PROCEDURE', 'description': 'Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.', 'armGroupLabels': ['Adductor canal', 'Femoral']}, {'name': 'Intravenous analgesia', 'type': 'PROCEDURE', 'description': 'Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.', 'armGroupLabels': ['Adductor canal', 'Controls', 'Femoral']}, {'name': 'Ropivacaine 0,75%', 'type': 'DRUG', 'armGroupLabels': ['Adductor canal', 'Femoral']}, {'name': 'Levobupivacaine 0,5%', 'type': 'DRUG', 'armGroupLabels': ['Adductor canal', 'Controls', 'Femoral']}, {'name': 'Levobupivacaine 0,125%', 'type': 'DRUG', 'armGroupLabels': ['Adductor canal', 'Femoral']}, {'name': 'Ketorolac 30mg', 'type': 'DRUG', 'armGroupLabels': ['Adductor canal', 'Controls', 'Femoral']}, {'name': 'Morphine', 'type': 'DRUG', 'armGroupLabels': ['Adductor canal', 'Controls', 'Femoral']}, {'name': 'stimulong sono, Pajunk, Germany', 'type': 'DEVICE', 'armGroupLabels': ['Adductor canal', 'Femoral']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto ortopedico Gaetano Pini', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Gianluca Cappelleri, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASST Gaetano Pini-CTO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASST Gaetano Pini-CTO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Gianluca Cappelleri', 'investigatorAffiliation': 'ASST Gaetano Pini-CTO'}}}}