Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-03 @ 11:08 PM
Study NCT ID:
NCT01987128
Status:
COMPLETED
Last Update Posted:
2015-02-27
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Popliteal Sciatic Nerve Block: Intraneural or Extraneural?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-26', 'studyFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2013-11-18', 'lastUpdatePostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'onset time', 'timeFrame': 'every 2 minutes for a maximum of 30 minutes', 'description': 'Pinprick test evaluation on sciatic nerve territory:\n\nWith a 22G needle the blinded operator will assess sensitiveness to puncture and then assign a score every 2 minutes for 30 minutes. A score of 0 will describe no sensation to puncture, on the other hand a score of 1 will be assigned if sensation to puncture is still present.\n\nEvaluation of motor blockade:\n\nPlantar and dorsal flexion of the foot will be evaluated for motor blockade of sciatic nerve. A score of 1 will be assigned if foot movement is conserved, 2 if is impaired and 3 when disappears.\n\nOnset time is described as the time at which pinprick score turns to 0 and motor blockade score turns to 3.'}], 'secondaryOutcomes': [{'measure': 'success rate in each group', 'timeFrame': 'at 30 minutes', 'description': 'Success rate is described as the percentage of subjects with an onset time within 30 minutes in a group among all subjects treated in that group'}, {'measure': 'Nerve injuries', 'timeFrame': '1, 5 weeks and at 6 months after surgery', 'description': 'Neurophysiological and clinic evaluation will be assessed either with clinical examination and electrophysiological tests by a neurophysiologist eventually evidencing any movement impairment or dysesthesia in the sciatic territory.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hallux Valgus']}, 'referencesModule': {'references': [{'pmid': '27281720', 'type': 'DERIVED', 'citation': 'Cappelleri G, Cedrati VL, Fedele LL, Gemma M, Camici L, Loiero M, Gallazzi MB, Cornaggia G. Effects of the Intraneural and Subparaneural Ultrasound-Guided Popliteal Sciatic Nerve Block: A Prospective, Randomized, Double-Blind Clinical and Electrophysiological Comparison. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):430-7. doi: 10.1097/AAP.0000000000000413.'}]}, 'descriptionModule': {'briefSummary': 'Aim of this study is to demonstrate the advantages of intraneural injection over extraneural injection in terms of onset and duration on peripheral block. In addition we will evaluate the frequency of possible adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n\nExclusion Criteria:\n\n* Neurological diseases\n* Diabetes\n* Allergies to used drugs\n* Chronic pain in treatment\n* Electrophysiological alterations at time zero analysis'}, 'identificationModule': {'nctId': 'NCT01987128', 'briefTitle': 'Popliteal Sciatic Nerve Block: Intraneural or Extraneural?', 'organization': {'class': 'OTHER', 'fullName': 'ASST Gaetano Pini-CTO'}, 'officialTitle': "Blocco Del Nervo Sciatico al Poplite, Intraneurale o Extraneurale? Confronto Prospettico, Randomizzato in Cieco Tra la modalità di Iniezione di Anestetico Locale Per il Blocco Eco Guidato Del Nervo Sciatico al Poplite Nella Chirurgia Dell'Alluce Valgo", 'orgStudyIdInfo': {'id': 'IOGPGC04-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraneural injection', 'description': 'All patients in the arm will receive a single intraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, in the sciatic nerve under echographic guidance.', 'interventionNames': ['Procedure: Intraneural injection', 'Drug: Ropivacaine', 'Device: PAJUNK SonoPlex 22G needle.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'extraneural injection', 'description': 'All patients in the arm will receive a single extraneural injection of 12 ml Ropivacaine 1% BBraun, Germany, around the sciatic nerve under echographic guidance.', 'interventionNames': ['Procedure: Extraneural injection', 'Drug: Ropivacaine', 'Device: PAJUNK SonoPlex 22G needle.']}], 'interventions': [{'name': 'Intraneural injection', 'type': 'PROCEDURE', 'description': 'BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.', 'armGroupLabels': ['Intraneural injection']}, {'name': 'Extraneural injection', 'type': 'PROCEDURE', 'description': 'BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.', 'armGroupLabels': ['extraneural injection']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'armGroupLabels': ['Intraneural injection', 'extraneural injection']}, {'name': 'PAJUNK SonoPlex 22G needle.', 'type': 'DEVICE', 'armGroupLabels': ['Intraneural injection', 'extraneural injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Ortopedico G. Pini', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Gianluca Cappelleri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ASST Gaetano Pini-CTO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ASST Gaetano Pini-CTO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Gianluca Cappelleri', 'investigatorAffiliation': 'ASST Gaetano Pini-CTO'}}}}