Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 1:53 AM
Study NCT ID:
NCT05728294
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2023-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups: femoral nerve block or sciatic nerve block with ropivacaine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2023-02-11', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intravenous morphine consumption', 'timeFrame': '24 hours after surgery', 'description': 'Intravenous morphine consumption (mg)'}], 'secondaryOutcomes': [{'measure': 'Intravenous morphine consumption', 'timeFrame': '2 hours after surgery', 'description': 'Intravenous morphine consumption (mg)'}, {'measure': 'Intravenous morphine consumption', 'timeFrame': '48 hours after surgery', 'description': 'Intravenous morphine consumption (mg)'}, {'measure': 'rest pain score', 'timeFrame': '2 hours after surgery', 'description': 'pain score at rest (visual analogue scale, 0-10)'}, {'measure': 'rest pain score', 'timeFrame': '24 hours after surgery', 'description': 'pain score at rest (visual analogue scale, 0-10)'}, {'measure': 'rest pain score', 'timeFrame': '48 hours after surgery', 'description': 'pain score at rest (visual analogue scale, 0-10)'}, {'measure': 'dynamic pain score', 'timeFrame': '2 hours after surgery', 'description': 'pain score on movement (visual analogue scale, 0-10)'}, {'measure': 'dynamic pain score', 'timeFrame': '24 hours after surgery', 'description': 'pain score on movement (visual analogue scale, 0-10)'}, {'measure': 'dynamic pain score', 'timeFrame': '48 hours after surgery', 'description': 'pain score on movement (visual analogue scale, 0-10)'}, {'measure': 'Rate of postoperative nausea and vomiting', 'timeFrame': '2 hours after surgery', 'description': 'number of events/total number of patients'}, {'measure': 'Rate of postoperative nausea and vomiting', 'timeFrame': '24 hours after surgery', 'description': 'number of events/total number of patients'}, {'measure': 'Rate of postoperative nausea and vomiting', 'timeFrame': '48 hours after surgery', 'description': 'number of events/total number of patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '38134484', 'type': 'DERIVED', 'citation': 'Kull C, Martin R, Rossel JB, Nguyen A, Albrecht E. Femoral vs sciatic nerve block to provide analgesia after medial open wedge high tibial osteotomy in the setting of multimodal analgesia: A randomized, controlled, single-blinded trial. J Clin Anesth. 2024 May;93:111355. doi: 10.1016/j.jclinane.2023.111355. Epub 2023 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to perform so that optimal postoperative analgesia is provided with minimum impact on the motor function. This randomised controlled double-blinded trial tested the hypothesis that a femoral nerve block provides superior analgesia than a sciatic nerve block after proximal tibial osteotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* proximal tibial osteotomy\n\nExclusion Criteria:\n\n* femoral or sciatic nerve deficit,\n* pre-existing peripheral neuropathy,\n* chronic pain diagnosis,\n* pregnancy,\n* identified contraindications to peripheral nerve block (e.g., local anesthetic allergy, coagulopathy, or infection at the block site).'}, 'identificationModule': {'nctId': 'NCT05728294', 'briefTitle': 'Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy', 'orgStudyIdInfo': {'id': '2018-01774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Femoral nerve block', 'description': 'Femoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL', 'interventionNames': ['Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml']}, {'type': 'EXPERIMENTAL', 'label': 'Sciatic nerve block', 'description': 'Sciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL', 'interventionNames': ['Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml']}], 'interventions': [{'name': 'Femoral nerve block with ropivacaine 0.5%, 20 ml', 'type': 'PROCEDURE', 'description': 'Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml', 'armGroupLabels': ['Femoral nerve block']}, {'name': 'Sciatic nerve block with ropivacaine 0.5%, 20 ml', 'type': 'PROCEDURE', 'description': 'Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml', 'armGroupLabels': ['Sciatic nerve block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'University Hospital of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Program Director, regional anaesthesia', 'investigatorFullName': 'Eric Albrecht', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}