Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2026-02-22 @ 7:03 AM
Study NCT ID:
NCT04102358
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2019-09-23', 'studyFirstSubmitQcDate': '2019-09-23', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Supplemented blocks', 'timeFrame': '1 hour', 'description': '30 minutes after the block, if one or two of the median, radial, ulnar or musculocutaneous nerves were still unblocked, these nerves were located either with a peripheric nerve stimulator or an ultrasound, in the axilla or on the more distal parts of their traces on arm and forearm and then supplemented.'}], 'secondaryOutcomes': [{'measure': 'Complete Failure', 'timeFrame': '30 minutes', 'description': 'If more than two of these nerves (median, radial, ulnar or musculocutaneous) were remained unblocked, no supplementary blocks were applied, then it was considered as having a failed block and general anesthesia was administered.'}, {'measure': 'Recovery of sensory block', 'timeFrame': '24 hours', 'description': 'the first time of the need for analgesics'}, {'measure': 'Discomfort during IC block', 'timeFrame': '1 hour', 'description': 'paresthesia during the infraclavicular block'}, {'measure': 'Inadvertent vascular puncture', 'timeFrame': '1 hour', 'description': 'inadvertent vascular puncture during the infraclavicular block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vertical infraclavicular block', 'brachial plexus anatomy'], 'conditions': ['Anesthesia, Regional']}, 'referencesModule': {'references': [{'pmid': '19174373', 'type': 'BACKGROUND', 'citation': 'Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26.'}, {'pmid': '28157792', 'type': 'BACKGROUND', 'citation': 'Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566.'}, {'pmid': '7611581', 'type': 'BACKGROUND', 'citation': 'Kilka HG, Geiger P, Mehrkens HH. [Infraclavicular vertical brachial plexus blockade. A new method for anesthesia of the upper extremity. An anatomical and clinical study]. Anaesthesist. 1995 May;44(5):339-44. doi: 10.1007/s001010050162. German.'}]}, 'descriptionModule': {'briefSummary': 'Theoretically, all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to clinical anesthesia, plexus, and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success and low risk of complications (1). In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.', 'detailedDescription': 'Theoretically all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to the clinical anesthesia, plexus and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success, and low risk of complications. At the same time, it was also shown that USG-guided IC blocks can shorten procedural times and accelerate the onset of the blocks.\n\nSeveral methods for IC blocks have been described. Based on the anatomical knowledge, we hypothesized that in medial approaches the need for supplementary blocks would be low with single injections as well as triple injections. In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.\n\nMedical records of 139 patients scheduled for elective or emergent hand, wrist, forearm, elbow, and distal arm surgery were analyzed. Patients older than 14 years with ASA physical status I-III who underwent surgery between October 2017 and March 2019 were retrospectively evaluated. Exclusion criteria included non-cooperative patients, refusal of the regional anesthesia, known neuropathy that could prevent the evaluation of the efficacy of the block, different techniques used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, …etc.), and known allergy to local anesthetic drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients underwent surgery for upper extremity under medial approach infraclavicular block between October 2017 and March 2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-III\n* upper extremity surgery\n* blocks were performed by the same anesthesiologist\n\nExclusion Criteria:\n\n* non-cooperative patients\n* refusal of the regional anesthesia\n* known neuropathy\n* different technique used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, …etc.)\n* known allergy to local anesthetic drugs.'}, 'identificationModule': {'nctId': 'NCT04102358', 'briefTitle': 'The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks', 'organization': {'class': 'OTHER', 'fullName': 'Derince Training and Research Hospital'}, 'officialTitle': 'The Need for Supplemental Blocks in Single Versus Triple Injections in Infraclavicular Brachial Plexus Blocks With Medial Approach: A Clinical and an Anatomical Study', 'orgStudyIdInfo': {'id': 'U1111-1240-8832'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single injection', 'description': 'Patients who received an infraclavicular block with a single injection technique were included in Group-S.', 'interventionNames': ['Procedure: Medial approach infraclavicular block with single injection']}, {'label': 'Triple injection', 'description': 'Patients who received an infraclavicular block with a triple injection technique were included in Group-T.', 'interventionNames': ['Procedure: Medial approach infraclavicular block with triple injection']}], 'interventions': [{'name': 'Medial approach infraclavicular block with single injection', 'type': 'PROCEDURE', 'description': 'infraclavicular blocks performed with single injection', 'armGroupLabels': ['Single injection']}, {'name': 'Medial approach infraclavicular block with triple injection', 'type': 'PROCEDURE', 'description': 'infraclavicular blocks performed with triple injection', 'armGroupLabels': ['Triple injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41900', 'city': 'Kocaeli', 'state': 'Derince', 'country': 'Turkey (Türkiye)', 'facility': 'Derince Training and Research Hospital', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Tuncay Colak, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Kocaeli University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available within 6 months of study completion.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.', 'accessCriteria': 'Data access requests will be reviewed by the researchers. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Derince Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hande Gurbuz', 'investigatorAffiliation': 'Derince Training and Research Hospital'}}}}