NCT05269251

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

February 25, 2022

Last Update Submit

February 29, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • tissue oxygenation

    Measured from both extremities by Near Infrared Spectroscopy for 30 min after brachial nerve block.

    30 minutes

Secondary Outcomes (1)

  • Radial artery diameter

    30 minutes

Study Arms (3)

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)

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)

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)

Interventions

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.

Also known as: Regional Oximetry System (O3™, Masimo, Irvine, CA)
Axillary Brachial Plexus BlockInfraclavicular Brachial Plexus BlockInterscalene Brachial Plexus Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demet Coskun

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Spectroscopy, Near-Infrared

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor M.D

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 7, 2022

Study Start

April 12, 2021

Primary Completion

May 31, 2022

Study Completion

August 1, 2022

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations