Effects of Brachial Plexus Block on Tissue Oxygenation (BrachialPlexus)

February 29, 2024 updated by: Demet Coşkun, Gazi University

Effects of Brachial Plexus Block Applied With Different Approaches on Tissue Oxygenation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Demet Coskun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Axillary Brachial Plexus Block
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.
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.
Other Names:
  • Regional Oximetry System (O3™, Masimo, Irvine, CA)
Infraclavicular Brachial Plexus Block
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.
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.
Other Names:
  • Regional Oximetry System (O3™, Masimo, Irvine, CA)
Interscalene Brachial Plexus Block
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.
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.
Other Names:
  • Regional Oximetry System (O3™, Masimo, Irvine, CA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tissue oxygenation
Time Frame: 30 minutes
Measured from both extremities by Near Infrared Spectroscopy for 30 min after brachial nerve block.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial artery diameter
Time Frame: 30 minutes
measured on the side of the block after brachial nerve block
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 7, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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