Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-30 @ 8:46 AM
Study NCT ID:
NCT01005550
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2009-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005265', 'term': 'Femoral Neck Fractures'}], 'ancestors': [{'id': 'D006620', 'term': 'Hip Fractures'}, {'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': '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-23', 'studyFirstSubmitDate': '2009-08-14', 'studyFirstSubmitQcDate': '2009-10-30', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.', 'timeFrame': '1 hour (surgery intervention)'}], 'secondaryOutcomes': [{'measure': 'Spinal anaesthesia characteristics', 'timeFrame': '1 hour (surgery intervention)'}, {'measure': 'Hemodynamics consequences', 'timeFrame': '1 hour (surgery intervention)'}, {'measure': 'Patient and surgeon satisfaction', 'timeFrame': '1 hour (surgery intervention)'}, {'measure': 'Morbidity and mortality', 'timeFrame': 'During 3 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Unilateral spinal anaesthesia', 'Hypobaric anaesthesia', 'Ropivacaine', 'Traumatic hip surgery'], 'conditions': ['Femoral Neck Fracture']}, 'referencesModule': {'references': [{'pmid': '23592605', 'type': 'RESULT', 'citation': 'Lilot M, Meuret P, Bouvet L, Caruso L, Dabouz R, Deleat-Besson R, Rousselet B, Thouverez B, Zadam A, Allaouchiche B, Boselli E. Hypobaric spinal anesthesia with ropivacaine plus sufentanil for traumatic femoral neck surgery in the elderly: a dose-response study. Anesth Analg. 2013 Jul;117(1):259-64. doi: 10.1213/ANE.0b013e31828f29f8. Epub 2013 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 70\n* dorsal decubitus surgery\n* ASA score 1, 2, 3\n* MMS score \\> or equal to 25\n\nExclusion Criteria:\n\n* local anesthetic allergy\n* spinal anaesthetic exclusion\n* MMS score lower than 25'}, 'identificationModule': {'nctId': 'NCT01005550', 'briefTitle': 'Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study', 'orgStudyIdInfo': {'id': '2008.519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6 mg of ropivacaine', 'description': '6 mg of ropivacaine are used for the spinal anaesthesia', 'interventionNames': ['Drug: 6 mg of ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': '8 mg of ropivacaine', 'description': '8 mg of ropivacaine are used for the spinal anaesthesia', 'interventionNames': ['Drug: 8 mg of ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': '10 mg of ropivacaine', 'description': '10 mg of ropivacaine are used for the spinal anaesthesia', 'interventionNames': ['Drug: 10 mg of ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': '12 mg of ropivacaine', 'description': '12 mg of ropivacaine are used for the spinal anaesthesia', 'interventionNames': ['Drug: 12 mg of ropivacaine']}], 'interventions': [{'name': '6 mg of ropivacaine', 'type': 'DRUG', 'description': '6 mg of ropivacaine are used for the spinal anaesthesia', 'armGroupLabels': ['6 mg of ropivacaine']}, {'name': '8 mg of ropivacaine', 'type': 'DRUG', 'description': '8 mg of ropivacaine are used for the spinal anaesthesia', 'armGroupLabels': ['8 mg of ropivacaine']}, {'name': '10 mg of ropivacaine', 'type': 'DRUG', 'description': '10 mg of ropivacaine for the spinal anaesthesia', 'armGroupLabels': ['10 mg of ropivacaine']}, {'name': '12 mg of ropivacaine', 'type': 'DRUG', 'description': '12 mg of ropivacaine for the spinal anaesthesia', 'armGroupLabels': ['12 mg of ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Pascal MEURET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}