Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT02451605
Status:
UNKNOWN
Last Update Posted:
2015-05-22
First Post:
2015-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regional Anesthesia for Knee Prothesis Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-21', 'studyFirstSubmitDate': '2015-05-12', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain measurement with numeric pain scale : from 0 to 10 (maximal pain) in rest condition', 'timeFrame': 'up to day 7', 'description': 'Pain assessment and evolution in postoperative period (passive condition)'}, {'measure': 'Pain measurement with numeric pain scale (from 0 to 10) during active motorized mobilization (Kinetic)', 'timeFrame': 'up to day 7', 'description': 'Pain assessment and evolution in postoperative period (active condition)'}], 'secondaryOutcomes': [{'measure': 'Postintervention nausea vomiting', 'timeFrame': 'at hour 0, at hours 6, at day 1', 'description': 'question : present or not'}, {'measure': 'Patient satisfaction', 'timeFrame': 'at day 1', 'description': 'Questionnaire of patient felling and satisfaction. Choice within gradual felling : bad, middle, good, excellent'}, {'measure': 'Opioid consumption', 'timeFrame': 'up to 48 hours', 'description': 'doses of piritramid (synthetic opioid) administrated with patient control rescue analgesia device.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surgery'], 'conditions': ['Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.', 'detailedDescription': 'Adductor canal block shows a beneficial effect for knee surgery. Mainly because he prevent for muscular weakness; adverse effect meet with femoral block and delaying the early active mobilization.\n\nThe investigators want to compare the efficacy and safety of this block compared to the femoral and sciatic block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for total knee replacement surgery.\n\nExclusion Criteria:\n\n* refusal to study,\n* coagulation disorder,\n* infection at the puncture site,\n* preexisting neuropathy,\n* allergy to local anesthetics,\n* renal or hepatocellular insufficiency,\n* context of chronic pain,\n* drugs abuse,\n* pregnant patient.'}, 'identificationModule': {'nctId': 'NCT02451605', 'briefTitle': 'Regional Anesthesia for Knee Prothesis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Regional Blockade for Knee Prothesis Surgery: Comparison Between Femoral, Sciatic and Adductor Canal Block', 'orgStudyIdInfo': {'id': '2014-000677-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral nerve blockade', 'description': 'In this group, patient will benefit of an ultrasound guided femoral nerve blockade with continuous catheter infusion as (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery.', 'interventionNames': ['Drug: Analgesic nerve blockade (Ropivacaine)', 'Procedure: Total knee replacement surgery.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor canal blockade', 'description': 'In this group, patient will benefit of an ultrasound guided adductor canal blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for for total knee replacement surgery.', 'interventionNames': ['Drug: Analgesic nerve blockade (Ropivacaine)', 'Procedure: Total knee replacement surgery.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subgluteal sciatic nerve blockade', 'description': 'In this group, patient will benefit of an ultrasound guided subgluteal sciatic nerve blockade with continuous catheter infusion (initial bolus of 20ml of ropivacaine 0.75% follow with 7ml/hour of ropivacaine 0.2%) as analgesic nerve blockade for total knee replacement surgery.', 'interventionNames': ['Drug: Analgesic nerve blockade (Ropivacaine)', 'Procedure: Total knee replacement surgery.']}], 'interventions': [{'name': 'Analgesic nerve blockade (Ropivacaine)', 'type': 'DRUG', 'otherNames': ['Regional anesthesia'], 'description': 'Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.', 'armGroupLabels': ['Adductor canal blockade', 'Femoral nerve blockade', 'Subgluteal sciatic nerve blockade']}, {'name': 'Total knee replacement surgery.', 'type': 'PROCEDURE', 'description': 'Total knee replacement surgery.', 'armGroupLabels': ['Adductor canal blockade', 'Femoral nerve blockade', 'Subgluteal sciatic nerve blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'contacts': [{'name': 'Pierre Goffin', 'role': 'CONTACT', 'email': 'goffin.pjc@gmail.com', 'phone': '003243667180'}, {'name': 'Jean Pierre Lecoq', 'role': 'CONTACT', 'email': 'jplecoq@chu.ulg.ac.be', 'phone': '003243667180'}, {'name': 'Jean Pierre Lecoq, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philippe Gautier, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University og Liege, University Hospital', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Pierre Goffin', 'role': 'CONTACT', 'email': 'goffin.pjc@gmail.com', 'phone': '003243667178'}, {'name': 'Jean-Pierre Lecoq', 'role': 'CONTACT', 'email': 'jplecoq@chu.ulg.ac.be', 'phone': '003243667178'}], 'overallOfficials': [{'name': 'Jean-Francois Brichant', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Liege'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant', 'investigatorFullName': 'Pierre Goffin', 'investigatorAffiliation': 'University of Liege'}}}}