Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT05269251
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2022-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Brachial Plexus Block on Tissue Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019265', 'term': 'Spectroscopy, Near-Infrared'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}, 'targetDuration': '10 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-02-25', 'lastUpdatePostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tissue oxygenation', 'timeFrame': '30 minutes', 'description': 'Measured from both extremities by Near Infrared Spectroscopy for 30 min after brachial nerve block.'}], 'secondaryOutcomes': [{'measure': 'Radial artery diameter', 'timeFrame': '30 minutes', 'description': 'measured on the side of the block after brachial nerve block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tissue Oxygenation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to measure the effects of sympathetic blockade caused by peripheral nerve blocks performed with the axillary, infraclavicular and interscalene approach on tissue oxygenation with Near Infrared Spectroscopy (NIRS), to evaluate and compare the radial artery flow velocity and diameter in the blocked extremity, and to investigate whether there is a relationship with the quality of the sensory and motor block.', 'detailedDescription': 'It has been reported that vasodilation after peripheral nerve blocks increases tissue oxygenation and increases arterial circulation on the ipsilateral side . Near Infrared Spectroscopy (NIRS), a noninvasive measurement method of tissue oxygen level, is used to measure regional hemoglobin oxygen saturation of arterial, venous and capillary blood .\n\nMany studies have compared the effects of upper extremity peripheral nerve blocks on the onset, quality, extent, and postoperative pain of sensory and motor block through axillary, infraclavicular, supraclavicular and interscalene approaches.\n\nThe aim of this study is to measure the effects of sympathetic blockade caused by peripheral nerve blocks performed with the axillary, infraclavicular and interscalene approach on tissue oxygenation with Near Infrared Spectroscopy (NIRS), to evaluate and compare the radial artery flow velocity and diameter in the blocked extremity, and to investigate whether there is a relationship with the quality of the sensory and motor block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ASA I-III patients aged 18-65 years, who were decided to apply axillary,infraclavicular and interscalene blocks as the anesthesia method, will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients\n* Patients between the ages of 18 and 65\n* Patients who applied axillary block\n* Patients who applied infraclavicular block\n* Patients who applied interscalene block\n\nExclusion Criteria:\n\n* Peripheral nerve disease a history\n* History of thrombosis in the extremity to be blocked\n* History of embolism in the extremity to be blocked\n* Presence of neuropathy'}, 'identificationModule': {'nctId': 'NCT05269251', 'acronym': 'BrachialPlexus', 'briefTitle': 'Effects of Brachial Plexus Block on Tissue Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Effects of Brachial Plexus Block Applied With Different Approaches on Tissue Oxygenation', 'orgStudyIdInfo': {'id': '357'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Axillary Brachial Plexus Block', 'description': 'Our study includes 3 groups, 33 patients each who underwent axillary, infraclavicular and interscalene blocks. In the study, which of the axillary, infraclavicular and interscalene blocks will be preferred, will be decided by an experienced anesthesiologist in accordance with the type of surgery to be performed. Demographic data, comorbidities, and smoking will be questioned in each group, arterial blood pressure, heart rate, body temperature, radial artery diameter and flow velocities will be recorded before peripheral nerve block is applied, and tissue oxygenation will be measured with Near Infrared Spectroscopy (NIRS) in the extremities with and without block. Tissue oxygenation, radial artery flow velocity and diameters, body temperature will be measured simultaneously at 0(basal)-5-10-15-20-25 and 30th minutes after the application of the block. test will be applied and the success of the procedure will be determined accordingly.', 'interventionNames': ['Device: Near Infrared Spectroscopy (NIRS)']}, {'label': 'Infraclavicular Brachial Plexus Block', 'description': 'Our study includes 3 groups, 33 patients each who underwent axillary, infraclavicular and interscalene blocks. In the study, which of the axillary, infraclavicular and interscalene blocks will be preferred, will be decided by an experienced anesthesiologist in accordance with the type of surgery to be performed. Demographic data, comorbidities, and smoking will be questioned in each group, arterial blood pressure, heart rate, body temperature, radial artery diameter and flow velocities will be recorded before peripheral nerve block is applied, and tissue oxygenation will be measured with Near Infrared Spectroscopy (NIRS) in the extremities with and without block. Tissue oxygenation, radial artery flow velocity and diameters, body temperature will be measured simultaneously at 0(basal)-5-10-15-20-25 and 30th minutes after the application of the block. test will be applied and the success of the procedure will be determined accordingly.', 'interventionNames': ['Device: Near Infrared Spectroscopy (NIRS)']}, {'label': 'Interscalene Brachial Plexus Block', 'description': 'Our study includes 3 groups, 33 patients each who underwent axillary, infraclavicular and interscalene blocks. In the study, which of the axillary, infraclavicular and interscalene blocks will be preferred, will be decided by an experienced anesthesiologist in accordance with the type of surgery to be performed. Demographic data, comorbidities, and smoking will be questioned in each group, arterial blood pressure, heart rate, body temperature, radial artery diameter and flow velocities will be recorded before peripheral nerve block is applied, and tissue oxygenation will be measured with Near Infrared Spectroscopy (NIRS) in the extremities with and without block. Tissue oxygenation, radial artery flow velocity and diameters, body temperature will be measured simultaneously at 0(basal)-5-10-15-20-25 and 30th minutes after the application of the block. test will be applied and the success of the procedure will be determined accordingly.', 'interventionNames': ['Device: Near Infrared Spectroscopy (NIRS)']}], 'interventions': [{'name': 'Near Infrared Spectroscopy (NIRS)', 'type': 'DEVICE', 'otherNames': ['Regional Oximetry System (O3™, Masimo, Irvine, CA)'], 'description': 'After the brachial plexus block, the regional oxygen saturation (rSO2) was monitored for 30 minutes with the Regional Oximetry System (O3™, Masimo, Irvine, CA) and the radial artery diameter with ultrasound in the same period.', 'armGroupLabels': ['Axillary Brachial Plexus Block', 'Infraclavicular Brachial Plexus Block', 'Interscalene Brachial Plexus Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Demet Coskun', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor M.D', 'investigatorFullName': 'Demet Coşkun', 'investigatorAffiliation': 'Gazi University'}}}}