Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-29 @ 4:25 PM
Study NCT ID:
NCT01033006
Status:
COMPLETED
Last Update Posted:
2014-02-13
First Post:
2009-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axillary Plexus Block in a High Resolution MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-12', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical efficacy of the blocks used compared with MRI findings', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Peripheral Nerves', 'Axillary Block', 'MRI'], 'conditions': ['Nerve Block', 'Magnetic Resonance Imaging']}, 'referencesModule': {'references': [{'pmid': '25051144', 'type': 'DERIVED', 'citation': 'Kjelstrup T, Hol PK, Courivaud F, Smith HJ, Rokkum M, Klaastad O. MRI of axillary brachial plexus blocks: a randomised controlled study. Eur J Anaesthesiol. 2014 Nov;31(11):611-9. doi: 10.1097/EJA.0000000000000122.'}], 'seeAlsoLinks': [{'url': 'http://ivs.no', 'label': 'The Intervention Centre'}]}, 'descriptionModule': {'briefSummary': 'Background and aims:\n\nMagnetic resonance imaging (MRI) has proved beneficial for presenting anatomy for regional anaesthesia and to demonstrate spread of local anaesthetic.\n\nA new axillary plexus block with a triple injection (1), combining a short axillary catheter method with a transarterial axillary block, is now being evaluated with a 3 Tesla MRI. In this study, the investigators are investigating MR visualisation of three different block techniques and compare the clinical efficacy of the techniques, with the MR findings.\n\nPatients \\& Methods:\n\nAfter obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult patients, scheduled for hand surgery, were included in a randomised, blinded prospective study.', 'detailedDescription': 'After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult patients, scheduled for hand surgery, were included in a randomised, blinded prospective study.\n\nIn all patients a short axillary plexus catheter is positioned close to the median nerve using nerve stimulator.\n\nTechnique 1 = 40 ml in catheter Technique 2 = 30 ml behind and 10 ml in front of the brachial artery (BA) Technique 3 = 20 ml behind, 10ml in front of the BA and 10 ml in catheter\n\nClinical High Field MRI (3T) scanner has simplified the recognition of brachial plexus nerves in the axilla. After injection of local anaesthetic (LA), the identification of the nerve structures is nevertheless difficult. When all nerves are surrounded of LA in the axilla (MRI), it seems to be associated with a clinical complete brachial plexus block'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for hand surgery\n* ASA 1 - 2\n* Weight from 50 - 95 kg\n* MR compatible, suitable\n\nExclusion Criteria:\n\n* Neurologic deficit\n* Reaction to LA'}, 'identificationModule': {'nctId': 'NCT01033006', 'briefTitle': 'Axillary Plexus Block in a High Resolution MRI', 'organization': {'class': 'OTHER', 'fullName': 'Diakonhjemmet Hospital'}, 'officialTitle': 'Axillary Plexus Block in a High Resolution MRI', 'orgStudyIdInfo': {'id': 'S-04115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: catheter injection', 'description': '40 ml of LA through the catheter', 'interventionNames': ['Procedure: Active Comparator: Arm 1: catheter injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: transarterial injection', 'description': '30 ml deep and 10 ml superficial to the artery', 'interventionNames': ['Procedure: Active Comparator: Arm 2: transarterial injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3: catheter and transarterial injection', 'description': '20 + 10 ml transarterial block and 10 ml through the catheter', 'interventionNames': ['Procedure: Active Comparator: Arm 3: catheter and transarterial injection']}], 'interventions': [{'name': 'Active Comparator: Arm 1: catheter injection', 'type': 'PROCEDURE', 'armGroupLabels': ['Arm 1: catheter injection']}, {'name': 'Active Comparator: Arm 2: transarterial injection', 'type': 'PROCEDURE', 'armGroupLabels': ['Arm 2: transarterial injection']}, {'name': 'Active Comparator: Arm 3: catheter and transarterial injection', 'type': 'PROCEDURE', 'armGroupLabels': ['Arm 3: catheter and transarterial injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'The Intervention Centre, Rikshospitalet, Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Trygve TK Kjelstrup, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diakonhjemmet Sykehus, University of Oslo'}, {'name': 'Øivind ØK Klaastad, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rikshospitalet, Dep. of Anesthesiology, Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diakonhjemmet Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Section manager', 'investigatorFullName': 'Trygve Kjelstrup, MD', 'investigatorAffiliation': 'Diakonhjemmet Hospital'}}}}