Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT01194505
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2010-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient, the orphopaedic surgeon and the anesthesiologist in the OR did not know at which group the patient belonged to.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2010-09-01', 'studyFirstSubmitQcDate': '2010-09-02', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale', 'timeFrame': '45 min', 'description': 'If the patient complains for pain \\> 4 in VAS and there is no relief with fentanyl administration the anesthesia plan converts to general anesthesia with laryngeal mask'}], 'secondaryOutcomes': [{'measure': 'Intraoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block', 'timeFrame': 'Intraoperatively'}, {'measure': 'Postoperative opioid consumption for ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block', 'timeFrame': '24h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anterior cruciate ligament reconstruction', 'obturator nerve block', 'sciatic nerve block', 'femoral nerve block', 'posterior lumbar plexus block', 'ultrasound guided nerve block'], 'conditions': ['Anterior Cruciate Ligament', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '20094695', 'type': 'BACKGROUND', 'citation': 'Zwissler B. [An exceptional author and publisher is leaving : Retirement of Reinhard Larsen from the editorial board of Der Anaesthesist]. Anaesthesist. 2010 Jan;59(1):5-6. doi: 10.1007/s00101-009-1649-2. No abstract available. German.'}, {'pmid': '15690265', 'type': 'BACKGROUND', 'citation': 'Enneking FK, Chan V, Greger J, Hadzic A, Lang SA, Horlocker TT. Lower-extremity peripheral nerve blockade: essentials of our current understanding. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):4-35. doi: 10.1016/j.rapm.2004.10.002. No abstract available.'}, {'pmid': '9527749', 'type': 'BACKGROUND', 'citation': 'Fanelli G, Casati A, Aldegheri G, Beccaria P, Berti M, Leoni A, Torri G. Cardiovascular effects of two different regional anaesthetic techniques for unilateral leg surgery. Acta Anaesthesiol Scand. 1998 Jan;42(1):80-4. doi: 10.1111/j.1399-6576.1998.tb05084.x.'}, {'pmid': '15781509', 'type': 'BACKGROUND', 'citation': 'Hadzic A, Karaca PE, Hobeika P, Unis G, Dermksian J, Yufa M, Claudio R, Vloka JD, Santos AC, Thys DM. Peripheral nerve blocks result in superior recovery profile compared with general anesthesia in outpatient knee arthroscopy. Anesth Analg. 2005 Apr;100(4):976-981. doi: 10.1213/01.ANE.0000150944.95158.B9.'}, {'pmid': '14500148', 'type': 'BACKGROUND', 'citation': 'Jankowski CJ, Hebl JR, Stuart MJ, Rock MG, Pagnano MW, Beighley CM, Schroeder DR, Horlocker TT. A comparison of psoas compartment block and spinal and general anesthesia for outpatient knee arthroscopy. Anesth Analg. 2003 Oct;97(4):1003-1009. doi: 10.1213/01.ANE.0000081798.89853.E7.'}, {'pmid': '15968551', 'type': 'BACKGROUND', 'citation': 'Morin AM, Pandurovic M, Eberhart LH, Wagner S, Kunz C, Nussle W, Geiger P, Mehrkens HH. [Is a blockade of the lateral cutaneous nerve of the thigh an alternative to the classical femoral nerve blockade for knee joint arthroscopy? A randomised controlled study]. Anaesthesist. 2005 Oct;54(10):991-9. doi: 10.1007/s00101-005-0879-1. German.'}, {'pmid': '19672183', 'type': 'BACKGROUND', 'citation': 'Heller AR, Fuchs A, Rossel T, Vicent O, Wiessner D, Funk RH, Koch T, Litz RJ. Precision of traditional approaches for lumbar plexus block: impact and management of interindividual anatomic variability. Anesthesiology. 2009 Sep;111(3):525-32. doi: 10.1097/ALN.0b013e3181af64b6.'}, {'pmid': '4796576', 'type': 'BACKGROUND', 'citation': 'Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available.'}, {'pmid': '17576526', 'type': 'BACKGROUND', 'citation': 'Kessler J, Marhofer P, Rapp HJ, Hollmann MW. [Ultrasound-guided anaesthesia of peripheral nerves. The new challenge for anaesthesiologists]. Anaesthesist. 2007 Jul;56(7):642-55. doi: 10.1007/s00101-007-1223-8. German.'}, {'pmid': '19843807', 'type': 'BACKGROUND', 'citation': 'Danelli G, Ghisi D, Fanelli A, Ortu A, Moschini E, Berti M, Ziegler S, Fanelli G. The effects of ultrasound guidance and neurostimulation on the minimum effective anesthetic volume of mepivacaine 1.5% required to block the sciatic nerve using the subgluteal approach. Anesth Analg. 2009 Nov;109(5):1674-8. doi: 10.1213/ANE.0b013e3181b92372.'}, {'pmid': '16301239', 'type': 'BACKGROUND', 'citation': 'Klein SM, Evans H, Nielsen KC, Tucker MS, Warner DS, Steele SM. Peripheral nerve block techniques for ambulatory surgery. Anesth Analg. 2005 Dec;101(6):1663-1676. doi: 10.1213/01.ANE.0000184187.02887.24.'}, {'pmid': '10021959', 'type': 'BACKGROUND', 'citation': "Greengrass RA, Klein SM, D'Ercole FJ, Gleason DG, Shimer CL, Steele SM. Lumbar plexus and sciatic nerve block for knee arthroplasty: comparison of ropivacaine and bupivacaine. Can J Anaesth. 1998 Nov;45(11):1094-6. doi: 10.1007/BF03012398."}, {'pmid': '6051731', 'type': 'BACKGROUND', 'citation': 'Freeman MA, Wyke B. The innervation of the knee joint. An anatomical and histological study in the cat. J Anat. 1967 Jun;101(Pt 3):505-32. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'Boezaart A. Continuous femoral Nerve Block for Pain Management in Total Knee Arthoplasty. AAOS, Orthopaedic Knowledge On Line'}, {'pmid': '24363843', 'type': 'BACKGROUND', 'citation': 'Simeoforidou M, Bareka M, Basdekis G, Tsiaka K, Chantzi E, Vretzakis G. Peripheral nerve blockade as an exclusive approach to obturator nerve block in anterior cruciate ligament reconstructive surgery. Korean J Anesthesiol. 2013 Nov;65(5):410-7. doi: 10.4097/kjae.2013.65.5.410. Epub 2013 Nov 29.'}, {'pmid': '28315922', 'type': 'BACKGROUND', 'citation': 'Bareka M, Hantes M, Arnaoutoglou E, Vretzakis G. Superior perioperative analgesia with combined femoral-obturator-sciatic nerve block in comparison with posterior lumbar plexus and sciatic nerve block for ACL reconstructive surgery. Knee Surg Sports Traumatol Arthrosc. 2018 Feb;26(2):478-484. doi: 10.1007/s00167-017-4525-7. Epub 2017 Mar 18.'}]}, 'descriptionModule': {'briefSummary': 'Anterior Cruciate Ligament ACL reconstruction can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-50 years old\n* ASA I - II\n* ACL reconstruction surgery\n\nExclusion Criteria:\n\n* Coagulopathy disorders\n* Infection at the puncture site for the interscalene block\n* Neurologic deficit in the arm that is going to be operated\n* Allergy to local anesthetics\n* BMI \\> 35\n* Psychiatric disorders\n* Patient's refusal\n* Problems with patient communication"}, 'identificationModule': {'nctId': 'NCT01194505', 'briefTitle': 'Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL)', 'organization': {'class': 'OTHER', 'fullName': 'Larissa University Hospital'}, 'officialTitle': 'Comparison of Posterior Lumbar Plexus Block Plus Sciatic Nerve Block With Sciatic Plus Femoral Plus Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': 'ACLObturator'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACL, sciatic, femoral, obturator', 'description': 'ACL reconstruction surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block', 'interventionNames': ['Other: Sciatic, femoral, obturator nerve blocks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACL, sciatic nerve block, posterior lumbar plexus block', 'description': 'ACL reconstruction surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block', 'interventionNames': ['Other: Sciatic nerve block, posterior lumbar plexus block']}], 'interventions': [{'name': 'Sciatic, femoral, obturator nerve blocks', 'type': 'OTHER', 'description': 'Ultrasound guided blocks with ropivacaine', 'armGroupLabels': ['ACL, sciatic, femoral, obturator']}, {'name': 'Sciatic nerve block, posterior lumbar plexus block', 'type': 'OTHER', 'description': 'Ultrasound and neurostimulator nerve blocks with ropivacaine', 'armGroupLabels': ['ACL, sciatic nerve block, posterior lumbar plexus block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'Larissa University Hospital', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}], 'overallOfficials': [{'name': 'Metaxia Bareka, Medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Larissa University Hospital'}, {'name': 'George Vretzakis, Medicine', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Eleni Chantzi, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Michael Hantes, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}, {'name': 'Eleni Askitopoulou, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Heraklion University Hospital'}, {'name': 'Marina Simaioforidou, Medicine', 'role': 'STUDY_CHAIR', 'affiliation': 'Larissa University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Larissa University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Metaxia Bareka', 'investigatorAffiliation': 'Larissa University Hospital'}}}}