Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-22 @ 7:24 AM
Study NCT ID:
NCT00567450
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D008619', 'term': 'Mepivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2007-12-04', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve', 'timeFrame': '4h'}], 'secondaryOutcomes': [{'measure': 'intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, and its side effects.', 'timeFrame': '48h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sciatic block', 'ropivacaine', 'mepivacaine', 'locoregional anesthesia'], 'conditions': ['Subgluteal Sciatic Block']}, 'descriptionModule': {'briefSummary': 'In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.\n\nThis study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* surgery of the foot under sciatic block\n\nExclusion Criteria:\n\n* no indication of locoregional anesthesia\n* polyneuropathy or any neurological disease\n* know hypersensitivity to local anesthetics\n* porphyria\n* atrio-ventricular block\n* not controlled epilepsia\n* hypovolemia\n* pregnancy\n* anticoagulant treatment'}, 'identificationModule': {'nctId': 'NCT00567450', 'briefTitle': 'Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2007-002254-31'}, 'secondaryIdInfos': [{'id': 'EudraCT: 2007-002254-31'}, {'id': 'AFFSAPS: A70388-33'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': '30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%', 'interventionNames': ['Drug: ropivacaine plus mepivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'A', 'description': '30 ml of ropivacaine 0.75%', 'interventionNames': ['Drug: ropivacaine']}], 'interventions': [{'name': 'ropivacaine', 'type': 'DRUG', 'description': '30ml of a mixture of ropivacaïne 0.75%', 'armGroupLabels': ['A']}, {'name': 'ropivacaine plus mepivacaine', 'type': 'DRUG', 'description': '30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': "CHU d'Amiens, Pole Anesthesie Réanimation, Place Victor Pauchet", 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'Campana Philippe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anesthesiology department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof Herve Dupont', 'oldOrganization': 'Anesthesiology and Critical Care Department'}}}}