Upper Extremity FractureNCT04764591
Tissue Perfusion for Different Approaches of Brachial Plexus Block
A study testing Lateral sagittal approach and Costoclavicular approach in people with Upper Extremity Fracture and Regional Anesthesia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
To compare the two different approaches of infraclavicular brachial plexus block in forearm, wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor block onset time and total effect time, first analgesic time, side effects and complications, and duration of block application. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Extremity Fracture, Regional Anesthesia, Brachial Plexus Blocks
- What is being tested?
- Lateral sagittal approach and Costoclavicular approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
- American Society of Anesthesiologists class 1 to 3
- Ability to consent
Who cannot join
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Renal or hepatic insufficiency
- Coagulation disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Medicine Faculty
Zonguldak, Kozlu, 67600
About this study
Official title: Effect of Different Approaches of Infraclavicular Brachial Plexus Block on Tissue Perfusion: A Randomized Trial
To compare the two different approaches of infraclavicular brachial plexus block in forearm, wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor block onset time and total effect time, first analgesic time, side effects and complications, and duration of block application.
- Conditions
- Upper Extremity Fracture, Regional Anesthesia, Brachial Plexus Blocks, Perfusion Index, Tissue Perfusion
- Being tested
- Lateral sagittal approach, Costoclavicular approach
- Keywords
- lateral sagittal approach, costoclavicular approach, block success, perfusion index, brachial plexus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral sagittal approachOther
Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block
Costoclavicular approachOther
Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Lateral sagittal approach | Active comparator | Patients in this group will be randomized to receive a lateral sagittal approach for Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . Receives: Other: Lateral sagittal approach |
| Costoclavicular approach | Active comparator | Patients in this group will be randomized to receive a costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . Receives: Other: Costoclavicular approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index
the effect of the block on the perfusion index
Measured: up to motor block scale ≥3
tissue oxygenation
the effect of the block on the tissue oxygenation
Measured: up to motor block scale ≥3
Secondary outcomes (4)
motor block onset time
quality of motor block scale ≥2
Measured: Assessed 40 minutes after block completion
sensorial block onset time
quality of sensorial block scale ≥2
Measured: up to 24 hours
complications
block related complications such as pneumothorax, vascular injury, local anesthetic systemic toxicity
Measured: up to 24 hours
duration of block application
from the needle puncture to the end of the local anesthetic injection
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağdaş Baytar, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764591
- Sponsor's protocol ID
- 2020/24-10
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baytar C, Koksal BG. Effects of different approaches of infraclavicular brachial plexus block on perfusion index and tissue perfusion. Ann Med. 2025 Dec;57(1):2451765. doi: 10.1080/07853890.2025.2451765. Epub 2025 Jan 11.
PubMed 39797918
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Approaches of Infraclavicular Brachial Plexus Block on Tissue Perfusion: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04764591
- Acronym / sponsor ID
- 2020/24-10
- Conditions
- Upper Extremity Fracture, Regional Anesthesia, Brachial Plexus Blocks, Perfusion Index, Tissue Perfusion
- Keywords
- lateral sagittal approach, costoclavicular approach, block success, perfusion index, brachial plexus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Feb 2021 (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.
To compare the two different approaches of infraclavicular brachial plexus block in forearm, wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor block onset time and total effect time, first analgesic time, side effects and complications, and duration of block application.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral sagittal approach | Active comparator | Other: Lateral sagittal approachPatients in this group will be randomized to receive a lateral sagittal approach for Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . |
| Costoclavicular approach | Active comparator | Other: Costoclavicular approachPatients in this group will be randomized to receive a costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
- American Society of Anesthesiologists class 1 to 3
- Ability to consent
Key exclusion criteria (4 listed)
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Renal or hepatic insufficiency
- Coagulation disorders
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 |
|---|---|---|
| Lateral sagittal approachLateral sagittal approach for ultrasound guided infraclavicular brachial plexus block | Other | Lateral sagittal approach |
| Costoclavicular approachCostoclavicular approach for ultrasound guided infraclavicular brachial plexus block | Other | Costoclavicular approach |
Primary outcome
perfusion index
Time frame: up to motor block scale ≥3
the effect of the block on the perfusion index
tissue oxygenation
Time frame: up to motor block scale ≥3
the effect of the block on the tissue oxygenation
4 secondary outcomes
motor block onset time
Time frame: Assessed 40 minutes after block completion
sensorial block onset time
Time frame: up to 24 hours
complications
Time frame: up to 24 hours
duration of block application
Time frame: during the intervention
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 9 Feb 2024.
- Derived from this study: PubMed 39797918Baytar C, Koksal BG. Effects of different approaches of infraclavicular brachial plexus block on perfusion index and tissue perfusion. Ann Med. 2025 Dec;57(1):2451765. doi: 10.1080/07853890.2025.2451765. Epub 2025 Jan 11.
- 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?
A study testing Lateral sagittal approach and Costoclavicular approach in people with Upper Extremity Fracture and Regional Anesthesia, run by Zonguldak Bulent Ecevit 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 3 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 9 Feb 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?
perfusion index (time frame: up to motor block scale ≥3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04764591, which also lists 1 linked publication.
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 9 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.