Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:09 AM
Study NCT ID:
NCT01947660
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2013-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002481', 'term': 'Cellulitis'}], 'ancestors': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-17', 'studyFirstSubmitDate': '2013-09-17', 'studyFirstSubmitQcDate': '2013-09-17', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Septic complication in the operated limb', 'timeFrame': '28 days', 'description': 'Septic complication in the operated limb Pain score Nausea and vomiting'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteo Arthritis', 'Cellulitis']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery.\n\nThe study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteo arthritis or cellulitis requiring surgical intervention\n* anatomical possibility of regional anesthesia\n* age \\>18 ans\n* written informed consent\n\nExclusion Criteria:\n\n* loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple)\n* patient under tutelle or curatelle\n* pregnant or beast feeding woman'}, 'identificationModule': {'nctId': 'NCT01947660', 'acronym': 'ACOSM', 'briefTitle': 'Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery', 'orgStudyIdInfo': {'id': '5492'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous regional anesthesia', 'interventionNames': ['Drug: Systemic analgesia + Continuous regional anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Systemic analgesia', 'interventionNames': ['Drug: Systemic analgesia']}], 'interventions': [{'name': 'Systemic analgesia + Continuous regional anesthesia', 'type': 'DRUG', 'description': 'Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative', 'armGroupLabels': ['Continuous regional anesthesia']}, {'name': 'Systemic analgesia', 'type': 'DRUG', 'description': 'Systemic analgesia as usual', 'armGroupLabels': ['Systemic analgesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67400', 'city': 'Illkirch-Graffenstaden', 'state': 'Alsace', 'country': 'France', 'contacts': [{'name': 'Eric NOLL, PH', 'role': 'CONTACT', 'phone': '03 88 55 23 37'}, {'name': 'KEMPF, PU PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'NOLL, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'GAUDIAS, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'JENNY, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'CLAVERT, PU PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'LAALOU, PH', 'role': 'SUB_INVESTIGATOR'}, {'name': 'BOERI, PH', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CCOM', 'geoPoint': {'lat': 48.52894, 'lon': 7.71523}}], 'centralContacts': [{'name': 'Pierre DIEMUNSCH, PU PH', 'role': 'CONTACT', 'email': 'pierre.diemunsch@chru-strasbourg.fr', 'phone': '03 88 12 70 76'}, {'name': 'Eric NOLL, PH', 'role': 'CONTACT', 'email': 'eric.noll@chru-strasbourg.fr', 'phone': '03 88 55 23 37'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}