Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 9:18 AM
Study NCT ID:
NCT01522534
Status:
TERMINATED
Last Update Posted:
2019-11-20
First Post:
2012-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Double Blind Controlled Trial Comparing a Blind Sciatic Nerve Block in the Popliteal Fossa to Intravenous Morphine for Traumatic Severe Acute Pain in the Prehospital Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008619', 'term': 'Mepivacaine'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'not enough inclusions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-18', 'studyFirstSubmitDate': '2012-01-27', 'studyFirstSubmitQcDate': '2012-01-30', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale pain score', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Total dose of morphine', 'timeFrame': '60 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['injuries', 'pain', 'Block, Nerve', 'morphine', 'Prehospital Emergency Care'], 'conditions': ['Injuries', 'Pain', 'Emergencies']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the efficacity of a simple blind technic of loco regional anaesthesia of the sciatic nerve compared to the gold standard in emergency medecine : the intravenous morphine for treated the severe pain of leg, ankle or foot trauma in the prehospital setting and mountain rescue.', 'detailedDescription': 'Severe pain due to leg, ankle or foot trauma do not beneficiated of a simple loco regional anaesthesia technic. Loco regional anesthesia is superior to intravenous morphine for treating severe pain and specially during transportation and mobilization of the patient. The purpose of the study is to assessed a new technic of blind sciatic nerve block in the popliteal fossa in the pre hospital setting compared to the intravenous morphine. The blind technic is a modified technic of the classic sciatic nerve block with nerve stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe pain (VAS \\> or = 60mm); injuries of the leg, ankle or foot\n\nExclusion Criteria:\n\n* Hypersensitivity to student agents\n* Local infection\n* Nerve or vascular pathology in the affected limb, coagulation pathology,\n* Chronic use of opoids, use of opoids within 6 hours\n* Drug addiction\n* Pregnancy\n* Systolic blood pressure less than 90 mmHg\n* Respiratory rate less than 16 per minute\n* Glasgow coma scale \\< 14.'}, 'identificationModule': {'nctId': 'NCT01522534', 'acronym': 'BPOP', 'briefTitle': 'Randomized Double Blind Controlled Trial Comparing a Blind Sciatic Nerve Block in the Popliteal Fossa to Intravenous Morphine for Traumatic Severe Acute Pain in the Prehospital Setting', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Annecy Genevois'}, 'orgStudyIdInfo': {'id': 'chra-2009-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blind block with mepivacaine', 'description': 'Blind block with mepivacaine and intravenous morphine', 'interventionNames': ['Drug: Mepivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine', 'description': 'Intravenous Morphine and placebo blind block', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Mepivacaine', 'type': 'DRUG', 'otherNames': ['experimental group'], 'description': 'mepivacaine 1% 20 ml corresponding to 200 mg', 'armGroupLabels': ['Blind block with mepivacaine']}, {'name': 'Morphine', 'type': 'DRUG', 'otherNames': ['control group'], 'description': 'Morphine alone with a placebo nerve block', 'armGroupLabels': ['Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73208', 'city': 'Albertville', 'country': 'France', 'facility': "Centre Hospitalier d'Albertville moutiers", 'geoPoint': {'lat': 45.67452, 'lon': 6.39061}}, {'zip': '74374', 'city': 'Annecy', 'country': 'France', 'facility': "Centre Hospitalier de la Region d'Annecy", 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'Centre Hospitalier de Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de GRENOBLE', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '74110', 'city': 'Morzine', 'country': 'France', 'facility': "Centre medical d'Avoriaz", 'geoPoint': {'lat': 46.18149, 'lon': 6.70664}}, {'zip': '74700', 'city': 'Sallanches', 'country': 'France', 'facility': 'Centre Hospitalier Sallanches Chamonix', 'geoPoint': {'lat': 45.94423, 'lon': 6.63162}}], 'overallOfficials': [{'name': 'Francois Xavier AGERON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Annecy Genevois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Annecy Genevois', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}