Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT02071433
Status:
UNKNOWN
Last Update Posted:
2017-01-26
First Post:
2014-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Motor block', 'timeFrame': '2 days'}, {'measure': 'Pain (VAS)', 'timeFrame': '2 days'}, {'measure': 'Sensory blockade extent', 'timeFrame': '1 Day'}, {'measure': 'Time to rescue analgesic and post operative opioid consumption', 'timeFrame': '1 Day'}, {'measure': 'Overall Benefit of Analgesia Score (OBAS)', 'timeFrame': '6 weeks'}, {'measure': 'SF-12 score', 'timeFrame': '12 weeks'}, {'measure': 'KOOS-score', 'timeFrame': '12 weeks'}, {'measure': 'IKDC-score', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Saphenous nerve block', 'Adductor canal block', 'Anterior cruciate ligament', 'Pain management', 'Day care'], 'conditions': ['Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65 years\n* ASA status I - III\n* rupture of the anterior cruciate ligament.\n\nExclusion Criteria:\n\n* contraindication for regional anesthesia\n* allergy against local anesthetics\n* BMI \\> 35\n* pre-existing diagnosed neuropathy of the operated leg\n* ingestion of strong opioids\n* pregnancy or breastfeeding status\n* History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)'}, 'identificationModule': {'nctId': 'NCT02071433', 'briefTitle': 'Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery', 'orgStudyIdInfo': {'id': 'ACLS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Saphenous nerve blockade', 'description': 'Experimental treatment 15 mL of levobupivacaine 0.5%', 'interventionNames': ['Procedure: Saphenous nerve blockade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral nerve blockade', 'description': 'Standard treatment 15 mL of levobupivacaine 0.5%', 'interventionNames': ['Procedure: Femoral nerve blockade']}], 'interventions': [{'name': 'Saphenous nerve blockade', 'type': 'PROCEDURE', 'armGroupLabels': ['Saphenous nerve blockade']}, {'name': 'Femoral nerve blockade', 'type': 'PROCEDURE', 'armGroupLabels': ['Femoral nerve blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105 AZ', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'M.W. Hollmanm', 'role': 'CONTACT', 'email': 'm.w.hollmann@amc.uva.nl'}, {'name': 'Werner ten Hoope, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Academic Medical Centre Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Werner ten Hoope, MD', 'role': 'CONTACT', 'email': 'w.tenhoope@amc.uva.nl', 'phone': '0031-205663633'}, {'name': 'M.W. Hollmann, professor dr., MD', 'role': 'CONTACT', 'email': 'm.w.hollmann@amc.uva.nl', 'phone': '0031-205663633'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'W ten Hoope', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}