Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02084368
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Combined Lumbar Plexus and Sciatic Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000767', 'term': 'Anesthesia, Epidural'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-10', 'studyFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2014-03-10', 'lastUpdatePostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintenance time of sensory and motor nerve block', 'timeFrame': 'up to 24h after operation', 'description': 'from the end of injection of local anesthetic drug up to 24h after operation'}], 'secondaryOutcomes': [{'measure': 'The change of hemodynamics', 'timeFrame': '0, 5, 10, 20, 30, 60 min after injection', 'description': 'the changes of SBP and DBP at 0, 5, 10, 20, 30, 60 min after injection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['combined lumbar plexus and sciatic nerve block，', 'combined spinal and epidural anesthesia'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '8069988', 'type': 'RESULT', 'citation': 'Farny J, Girard M, Drolet P. Posterior approach to the lumbar plexus combined with a sciatic nerve block using lidocaine. Can J Anaesth. 1994 Jun;41(6):486-91. doi: 10.1007/BF03011542.'}, {'pmid': '21156977', 'type': 'RESULT', 'citation': 'de Leeuw MA, Slagt C, Hoeksema M, Zuurmond WW, Perez RS. Hemodynamic changes during a combined psoas compartment-sciatic nerve block for elective orthopedic surgery. Anesth Analg. 2011 Mar;112(3):719-24. doi: 10.1213/ANE.0b013e318206bc30. Epub 2010 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The research is to study the effectiveness and safety of combined lumbar plexus and sciatic nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee replacement.There have be some papers which supported that combined lumbar plexus and sciatic nerve block may be more suitable for the old men.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of American Association of anesthetists（ASA）Grade 1、2 or 3\n2. Aged between 18 and 85 years\n3. Undergoing elective total knee replacement.\n\nExclusion Criteria:\n\n1. Mental illness can not match\n2. Nerve block, epidural anesthesia contraindicated\n3. People who have Slow-type arrhythmias\n4. History of chronic headaches and long-term use of analgesic drugs\n5. People who were postoperative consciousness, language or hearing impaired'}, 'identificationModule': {'nctId': 'NCT02084368', 'briefTitle': 'Application of Combined Lumbar Plexus and Sciatic Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Guangzhou General Hospital of Guangzhou Military Command'}, 'officialTitle': 'Application of Combined Lumbar Plexus and Sciatic Nerve Block in Unilateral Knee Replacement', 'orgStudyIdInfo': {'id': 'Nerve Block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerve block', 'description': 'Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block guided by PNS.', 'interventionNames': ['Procedure: Nerve block', 'Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'combined spinal and epidural anesthesia', 'description': 'Combined spinal and epidural anesthesia were performed in patients of this group.', 'interventionNames': ['Procedure: Combined spinal and epidural anesthesia', 'Drug: Bupivacaine']}], 'interventions': [{'name': 'Nerve block', 'type': 'PROCEDURE', 'description': 'Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS', 'armGroupLabels': ['Nerve block']}, {'name': 'Combined spinal and epidural anesthesia', 'type': 'PROCEDURE', 'description': 'Combined spinal and epidural anesthesia were performed in patients of this group with 0.5% hyperbaric bupivacaine 8\\~10mg at L2-3 or L3-4.', 'armGroupLabels': ['combined spinal and epidural anesthesia']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['0.33%Ropivacaine'], 'description': 'Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.', 'armGroupLabels': ['Nerve block']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['0.5%Bupivacaine'], 'description': 'Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8\\~10mg.', 'armGroupLabels': ['combined spinal and epidural anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510010', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Military Region General Hospital, Department of Anesthesiology', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate chief physician', 'investigatorFullName': 'bo xu', 'investigatorAffiliation': 'Guangzhou General Hospital of Guangzhou Military Command'}}}}