Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-02-28 @ 11:20 AM
Study NCT ID:
NCT00988234
Status:
COMPLETED
Last Update Posted:
2011-02-17
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2009-10-01', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Block success defined as loss of sensation to pinprick in each of the lumbar plexus and sciatic nerve distributions when measured 30 min after block performance.', 'timeFrame': '30min'}, {'measure': 'Motor blockade was evaluated by assessing the strength of knee extension (femoral nerve), thigh adduction (obturator nerve), and plantar flexion and dorsiflexion of the ankle (sciatic nerve) 30 min after block performance.', 'timeFrame': '30min'}], 'secondaryOutcomes': [{'measure': 'block execution time, depth of the nerve, needle depth, duration of the sensory and motor blockade, complications such as inadvertent needle puncture of epidural space, dural puncture, peritoneal puncture, and kidney or ureter puncture and nerve injury.', 'timeFrame': 'within 48h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lumbar plexus block', 'sciatic nerve block', 'position', 'ultrasound guidance', 'elective lower limb surgery'], 'conditions': ['Lower Limb Surgery']}, 'descriptionModule': {'briefSummary': 'In the present study, the investigators will test the effect of two position on posterior lumbar plexus and subgluteal or sub-greater trochanter sciatic nerve block.', 'detailedDescription': 'The posterior lumbar plexus block approach was described approximately 30 years ago, using surface anatomical landmarks and a loss-of-resistance technique, but over the years it was almost abandoned for its low successful rate, the huge numbers of adverse effects and its difficulties to be performed. The introduction of the nerve stimulator and ultrasound guided technique in recent years increased the success rate in various peripheral nerve blocks and decreased adverse effects. Ultrasound guided LPB as well as sciatic nerve block technique in a small patient population resulting in a encouraging result, but published clinical data on optimal patient position for ultrasound-guided LPB are limited. We designed this prospective randomized study to compare the success rate, time of performance and complications of ultrasound guided posterior lumbar plexus block as well as subgluteal or sub-greater trochanter sciatic nerve block under lateral decubitus position v.s. prone position.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 75 years old\n* elective unilateral lower limb surgery\n* ASA Physical Status ASA I-III\n\nExclusion Criteria:\n\n* age \\<18 or \\>75 year old\n* ASA Physical Status \\>ASA III\n* abnormal blood coagulation\n* infection near puncture place\n* nerve injury\n* bilateral lower limb surgery\n* patients with lumbar vertebral trauma\n* inability to be properly positioned\n* chronic narcotic therapy or illicit drug use'}, 'identificationModule': {'nctId': 'NCT00988234', 'briefTitle': 'Comparison of Two Position for Ultrasound Guided Lumbar Plexus and Sciatic Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Comparison of Lateral Decubitus Position Versus Prone Position for Ultrasound Guided Posterior Lumbar Plexus Block and Sciatic Nerve Block', 'orgStudyIdInfo': {'id': 'TJHMZK01001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SGPP', 'description': 'ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position', 'interventionNames': ['Procedure: SGPP']}, {'type': 'EXPERIMENTAL', 'label': 'SGTPP', 'description': 'ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position', 'interventionNames': ['Procedure: SGTPP']}, {'type': 'EXPERIMENTAL', 'label': 'SGLP', 'description': 'ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position', 'interventionNames': ['Procedure: SGLP']}, {'type': 'EXPERIMENTAL', 'label': 'SGTLP', 'description': 'ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position', 'interventionNames': ['Procedure: SGTLP']}], 'interventions': [{'name': 'SGPP', 'type': 'PROCEDURE', 'description': 'ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under prone position', 'armGroupLabels': ['SGPP']}, {'name': 'SGTPP', 'type': 'PROCEDURE', 'description': 'ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under prone position', 'armGroupLabels': ['SGTPP']}, {'name': 'SGLP', 'type': 'PROCEDURE', 'description': 'ultrasound guided posterior lumbar plexus block and subgluteal sciatic nerve block under lateral decubitus position', 'armGroupLabels': ['SGLP']}, {'name': 'SGTLP', 'type': 'PROCEDURE', 'description': 'ultrasound guided posterior lumbar plexus block and sub-greater trochanter approach under lateral decubitus position', 'armGroupLabels': ['SGTLP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Yuke Tian, MD.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yuke Tian/ Professor', 'oldOrganization': 'Department of Anesthesiology, Tongji Hospital, Tongji medical college, Huazhong University of science and Technology'}}}}