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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05269251
Other study ID # 357
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2021
Est. completion date August 1, 2022

Study information

Verified date February 2024
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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 . Many 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date August 1, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - ASA I-III patients - Patients between the ages of 18 and 65 - Patients who applied axillary block - Patients who applied infraclavicular block - Patients who applied interscalene block Exclusion Criteria: - Peripheral nerve disease a history - History of thrombosis in the extremity to be blocked - History of embolism in the extremity to be blocked - Presence of neuropathy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Near Infrared Spectroscopy (NIRS)
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.

Locations

Country Name City State
Turkey Demet Coskun Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary tissue oxygenation Measured from both extremities by Near Infrared Spectroscopy for 30 min after brachial nerve block. 30 minutes
Secondary Radial artery diameter measured on the side of the block after brachial nerve block 30 minutes
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