Tissue OxygenationBrachialPlexusNCT05269251
Effects of Brachial Plexus Block on Tissue Oxygenation
An observational study of Tissue Oxygenation, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue Oxygenation
- What is being tested?
- Near Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2021to 1 Aug 2022
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Tissue Oxygenation
- Being tested
- Near Infrared Spectroscopy (NIRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy (NIRS)Device
Also called Regional Oximetry System (O3™, Masimo, Irvine, CA)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Near Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygenation
Measured from both extremities by Near Infrared Spectroscopy for 30 min after brachial nerve block.
Measured: 30 minutes
Secondary outcomes (1)
Radial artery diameter
measured on the side of the block after brachial nerve block
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start12 Apr 2021
- Primary completion31 May 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Coşkun, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269251
- Sponsor's protocol ID
- 357
- Acronym
- BrachialPlexus
- Status last verified
- Feb 2024
- First submitted
- 25 Feb 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brachial Plexus Block Applied With Different Approaches on Tissue Oxygenation
- ClinicalTrials.gov ID
- NCT05269251
- Acronym / sponsor ID
- BrachialPlexus / 357
- Conditions
- Tissue Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Axillary Brachial Plexus Block | – | Device: Near Infrared Spectroscopy (NIRS)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. |
| Infraclavicular Brachial Plexus Block | – | Device: Near Infrared Spectroscopy (NIRS)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. |
| Interscalene Brachial Plexus Block | – | Device: Near Infrared Spectroscopy (NIRS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared Spectroscopy (NIRS)Also: Regional Oximetry System (O3™, Masimo, Irvine, CA)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. | Device | Axillary Brachial Plexus Block, Infraclavicular Brachial Plexus Block, Interscalene Brachial Plexus Block |
Primary outcome
tissue oxygenation
Time frame: 30 minutes
Measured from both extremities by Near Infrared Spectroscopy for 30 min after brachial nerve block.
1 secondary outcome
Radial artery diameter
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Oxygenation, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue oxygenation (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.