Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-27 @ 12:44 AM
Study NCT ID:
NCT01726192
Status:
UNKNOWN
Last Update Posted:
2012-11-14
First Post:
2012-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Techniques for Placement of Perineural Femoral Catheters.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-13', 'studyFirstSubmitDate': '2012-11-09', 'studyFirstSubmitQcDate': '2012-11-13', 'lastUpdatePostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'incidence of side effects, consumption of iv analgesics', 'timeFrame': '36 hours postoperatively'}], 'primaryOutcomes': [{'measure': 'local anesthetic consumption', 'timeFrame': '36 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Pain scores with a VAS scale', 'timeFrame': '36 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Anterior Cruciate Ligament Reconstruction']}, 'referencesModule': {'references': [{'pmid': '22088876', 'type': 'BACKGROUND', 'citation': 'Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.', 'detailedDescription': 'The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.\n\nEach patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults\n* BMI less than 30\n\nExclusion Criteria:\n\n* known allergies to local anesthetics or other drugs used\n* patient refusal\n* any local or systemic contraindication to the use of popliteal block'}, 'identificationModule': {'nctId': 'NCT01726192', 'acronym': 'HLOCSTIM2', 'briefTitle': 'Comparison of Two Techniques for Placement of Perineural Femoral Catheters.', 'organization': {'class': 'OTHER', 'fullName': 'Attikon Hospital'}, 'officialTitle': 'Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.', 'orgStudyIdInfo': {'id': 'HLOCSTIM2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HLOC', 'description': 'Placement of a femoral catheter with the hydrolocalization technique', 'interventionNames': ['Procedure: Placement of a femoral catheter with the hydrolocalization technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NS', 'description': 'Placement of a femoral neurostimulating catheter', 'interventionNames': ['Procedure: Placement of a femoral neurostimulating catheter']}], 'interventions': [{'name': 'Placement of a femoral catheter with the hydrolocalization technique', 'type': 'PROCEDURE', 'otherNames': ['Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%'], 'description': 'Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%', 'armGroupLabels': ['HLOC']}, {'name': 'Placement of a femoral neurostimulating catheter', 'type': 'PROCEDURE', 'armGroupLabels': ['NS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Tatiana F Sidiropoulou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Theodosios Saranteas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Attikon Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mario Dauri, MD', 'role': 'CONTACT', 'email': 'mario.dauri@ptvonline.it'}, {'name': 'Mario Dauri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Tor Vergata', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Tatiana F Sidiropoulou, MD, PhD', 'role': 'CONTACT', 'email': 'tatianasid@gmail.com', 'phone': '00302105832371'}], 'overallOfficials': [{'name': 'Tatiana F Sidiropoulou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attikon Hospital'}, {'name': 'Theodosios Saranteas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Attikon Hospital'}, {'name': 'Mario Dauri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Tor Vergata'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attikon Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Anesthesiology, University of Athens', 'investigatorFullName': 'Sidiropoulou Tatiana', 'investigatorAffiliation': 'Attikon Hospital'}}}}