Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-04 @ 4:31 AM
Study NCT ID:
NCT02037633
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2014-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-15', 'studyFirstSubmitDate': '2014-01-12', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores on the Numeric Rating Scale', 'timeFrame': 'Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)'}], 'secondaryOutcomes': [{'measure': 'Duration of spinal anesthesia performance', 'timeFrame': 'Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)', 'description': 'It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal'}, {'measure': "Quality of patient's position", 'timeFrame': 'Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)', 'description': 'The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hip Fracture']}, 'referencesModule': {'references': [{'pmid': '19650803', 'type': 'BACKGROUND', 'citation': 'Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22.'}, {'pmid': '18762870', 'type': 'BACKGROUND', 'citation': 'Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.'}, {'pmid': '33238043', 'type': 'DERIVED', 'citation': 'Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hip fracture\n\nExclusion Criteria:\n\n* contraindications for central nervous blockade\n* impaired cognition or dementia\n* multiple fractures\n* any previous analgesic administration during the last 12 hours'}, 'identificationModule': {'nctId': 'NCT02037633', 'briefTitle': 'Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Asklepieion Voulas General Hospital'}, 'officialTitle': 'Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.', 'orgStudyIdInfo': {'id': '478-9227/25-7-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fascia iliaca compartment block', 'interventionNames': ['Procedure: Fascia iliaca compartment block', 'Drug: ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fentanyl', 'interventionNames': ['Drug: Fentanyl']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl IV', 'armGroupLabels': ['Fentanyl']}, {'name': 'Fascia iliaca compartment block', 'type': 'PROCEDURE', 'description': 'Fascia iliaca compartment block using ropivacaine', 'armGroupLabels': ['Fascia iliaca compartment block']}, {'name': 'ropivacaine', 'type': 'DRUG', 'armGroupLabels': ['Fascia iliaca compartment block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16673', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Asklepieion Hospital of Voula', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asklepieion Voulas General Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Maria Diakomi', 'investigatorAffiliation': 'Asklepieion Voulas General Hospital'}}}}