Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-22 @ 9:11 PM
Study NCT ID:
NCT02419261
Status:
UNKNOWN
Last Update Posted:
2018-03-22
First Post:
2015-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Adductor Canal Blockade in Anterior Cruciate Ligament Surgery
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-21', 'studyFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cold sensitivity assessment (cold, very cold, no sensation)', 'timeFrame': 'From 30 to 60 minutes after nerve blockade', 'description': 'sensitivity description (cold, very cold, no sensation)'}, {'measure': 'Motor blockade assessment (dynamometer)', 'timeFrame': 'From 30 to 60 minutes after nerve blockade', 'description': 'motor blockade evaluation with dynamometer'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain assessment (visual analgesic scale)', 'timeFrame': 'At 2, 4, 6 postoperative hours', 'description': 'Evaluation with visual analgesic scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['knee surgery', 'anterior cruciate ligament surgery', 'nerve block'], 'conditions': ['Surgery of Arthroscopic Anterior Cruciate Ligament Repair']}, 'descriptionModule': {'briefSummary': 'Assessment of sensory and motor blockade of adductor canal blockade performed for anterior cruciate ligament repair in comparison with femoral nerve blockade.', 'detailedDescription': 'The adductor canal blockade is a reliable technique for analgesia after knee surgery. It is a safe technique, avoiding muscle weakness, and by this way limiting the risk of fall. Injection of local anaesthetics in the adductor canal does not block the sole saphenous nerve. Demonstration of a proximal spreading, around the branches of the femoral nerve have been made. The aim of this study is to assess a possible spreading from the adductor to the the popliteal fossa, where sciatic nerve and its branches are located. Pinprick test all around the knee and the leg, combined with motor assessment of the muscle of the leg and the ankle will be realised. This assessment was compared with femoral nerve blockade, classically used for analgesia after this kind of surgery (anterior cruciate ligament repair)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for anterior cruciate ligament repair\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': 'NCT02419261', 'acronym': 'ACB', 'briefTitle': 'Assessment of Adductor Canal Blockade in Anterior Cruciate Ligament Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Assessment of Sensory and Motor Blockade of the Adductor Canal Blockade Performed for Surgery of Arthroscopic Anterior Cruciate Ligament Repair', 'orgStudyIdInfo': {'id': 'Gauthier - Lecoq - Goffin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Adductor Canal Blockade', 'description': 'In this group, patient will benefit of an ultrasound guided adductor canal blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair', 'interventionNames': ['Drug: Analgesic nerve blockade (Ropivacaine)', 'Procedure: Arthroscopic surgical repair of the anterior cruciate ligament']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral Nerve Blockade', 'description': 'In this group, patient will benefit of an ultrasound guided femoral nerve blockade (20 ml of Ropivacaine 0.75%) as analgesic nerve blockade for their surgery of anterior cruciate ligament repair', 'interventionNames': ['Drug: Analgesic nerve blockade (Ropivacaine)', 'Procedure: Arthroscopic surgical repair of the anterior cruciate ligament']}], 'interventions': [{'name': 'Analgesic nerve blockade (Ropivacaine)', 'type': 'DRUG', 'description': 'Analgesic nerve blockade for Arthroscopic surgical repair of the anterior cruciate ligament', 'armGroupLabels': ['Adductor Canal Blockade', 'Femoral Nerve Blockade']}, {'name': 'Arthroscopic surgical repair of the anterior cruciate ligament', 'type': 'PROCEDURE', 'armGroupLabels': ['Adductor Canal Blockade', 'Femoral Nerve Blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jean-Pierre H Lecoq, MD PhD', 'role': 'CONTACT', 'email': 'jplecoq@chu.ulg.ac.be', 'phone': '003243667180'}, {'name': 'Pierre J Goffin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philippe Gautier, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Liege, University Hospital', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Jean-Pierre H Lecoq, MD PhD', 'role': 'CONTACT', 'email': 'jplecoq@chu.ulg.ac.be', 'phone': '003243667180'}], 'overallOfficials': [{'name': 'Jean-Pierre H Lecoq, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liege, University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'J P Lecoq', 'investigatorAffiliation': 'University of Liege'}}}}