Costoclavicular and Infraclavicular Block for Patients Who Have Undergone Hand,Forearm and Arm SurgeryNCT04857216
Comparison of the Block Characteristics of USG Guided Costoclavicular and Infraclavicular Block With the Perfusion Index
An observational study of Costoclavicular and Infraclavicular Block for Patients Who Have Undergone Hand,Forearm and Arm Surgery, run by Izmir Ataturk Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
With this study, it was aimed to compare the block characteristics evaluated with traditional methods in infraclavicular and costoclavicular block applications performed in upper extremity surgery in our clinic with the perfusion index Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Costoclavicular and Infraclavicular Block for Patients Who Have Undergone Hand,Forearm and Arm Surgery
- What is being tested?
- Perfusion Index
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 14 Mar 2021to 30 Jul 2021
- How long will I take part?
- 3 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 years and older
- All sexes
- Adult, Older adult
Study population: All costoclavicular and infraclavicular block patients who have undergone hand,forearm and arm surgery over the age of 18
Who may be able to join
- All costoclavicular and infraclavicular block patients who have undergone hand,forearm and arm surgery
- Patients over the age of 18
Who cannot join
- Patients who do not want to participate in the study
- Patients whose peripheral block administration is contraindicated
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Katip Celebi University Atatürk Training and Research Hospital
Izmir, 35360
Katip Çelebi University İzmir Atatürk Training and Reseach Hospital
Izmir, 35360
About this study
Official title: Comparison of the Block Characteristics of Ultrasound Guided Costoclavicular and Infraclavicular Block With the Perfusion Index
With this study, it was aimed to compare the block characteristics evaluated with traditional methods in infraclavicular and costoclavicular block applications performed in upper extremity surgery in our clinic with the perfusion index
Read the detailed description
Peripheral nerve block is to anesthetize the dermatomes belonging to the nerve or nerve group to which the block is applied, by performing sympathetic, sensory and motor blocks. Brachial plexus blockade; It is a peripheral nerve blockage that can be used in surgical operations to be performed on the upper extremity and can be performed at the level of interscalene, supraclavicular, infraclavicular, costoclavicular, axillary and terminal nerves.
The costoclavicular brachial plexus block has been used as an alternative to lateral sagittal infraclavicular block, due to its ease of application, its rapid onset of action and its high success rate. The effectiveness of the block is measured by sensory, motor and sympathetic block effects. The sensory block can be evaluated by cold or pinprick test, and motor block by traditional methods such as the patient's response to verbal commands and can be objective.
Sympathetic block manifests itself with vasodilation and an increase in blood flow rate and can be measured with the more quantitative perfusion index (PI). The perfusion index represents the ratio of pulsatile blood flow to static blood flow in peripheral tissue and can be measured continuously and noninvasively from a pulse oximeter. Successful peripheral nerve blockade; It is seen as local vasodilation, increased local blood flow, some increase in skin temperature and loss of sensation in the extremity due to the blockage of sympathetic fibers. It can be a guide in determining the effectiveness of the block because it is noninvasive and easy, providing rapid evaluation, without requiring patient cooperation to evaluate the success of the block.
- Being tested
- Perfusion Index
- Keywords
- infraclavicular, costoclavicular, perfusion index, block
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perfusion IndexDevice
perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients
| Study group | Role | What they receive |
|---|---|---|
| Infraclavicular Group | Block Characteristics of Ultrasound Guided Infraclavicular Block with the Perfusion Index Receives: Device: Perfusion Index | |
| Costoclavicular Group | Block Characteristics of Ultrasound Guided costoclavicular Block with the Perfusion Index Receives: Device: Perfusion Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of perfusion index with infraclavicular and costoclavicular block success
Correlation of perfusion index with infraclavicular and costoclavicular block success
Measured: 3 Months
Secondary outcomes (1)
Comparison of the Block Characteristics of Ultrasound Guided Costoclavicular and Infraclavicular Block
Comparison of the Block Characteristics of Ultrasound Guided Costoclavicular and Infraclavicular Block
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start14 Mar 2021
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Costoclavicular and Infraclavicular Block for Patients Who Have Undergone Hand,Forearm and Arm SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Izmir Ataturk Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Arslan Yurtlu, Izmir Ataturk Training and Research Hospital
- Investigators
- Busra Serce, MD, Study director, KCU Izmir Atatürk Training And Research HospitalDerya Yurtlu, MD, Principal investigator, KCU Izmir Atatürk Training And Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857216
- Sponsor's protocol ID
- IATRH
- Status last verified
- Aug 2021
- First submitted
- 21 Apr 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Block Characteristics of Ultrasound Guided Costoclavicular and Infraclavicular Block With the Perfusion Index
- ClinicalTrials.gov ID
- NCT04857216
- Acronym / sponsor ID
- IATRH
- Keywords
- infraclavicular, costoclavicular, perfusion index, block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Izmir Ataturk Training and Research HospitalUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 23 Apr 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.
With this study, it was aimed to compare the block characteristics evaluated with traditional methods in infraclavicular and costoclavicular block applications performed in upper extremity surgery in our clinic with the perfusion index
Detailed description
Peripheral nerve block is to anesthetize the dermatomes belonging to the nerve or nerve group to which the block is applied, by performing sympathetic, sensory and motor blocks. Brachial plexus blockade; It is a peripheral nerve blockage that can be used in surgical operations to be performed on the upper extremity and can be performed at the level of interscalene, supraclavicular, infraclavicular, costoclavicular, axillary and terminal nerves.
The costoclavicular brachial plexus block has been used as an alternative to lateral sagittal infraclavicular block, due to its ease of application, its rapid onset of action and its high success rate. The effectiveness of the block is measured by sensory, motor and sympathetic block effects. The sensory block can be evaluated by cold or pinprick test, and motor block by traditional methods such as the patient's response to verbal commands and can be objective.
Sympathetic block manifests itself with vasodilation and an increase in blood flow rate and can be measured with the more quantitative perfusion index (PI). The perfusion index represents the ratio of pulsatile blood flow to static blood flow in peripheral tissue and can be measured continuously and noninvasively from a pulse oximeter. Successful peripheral nerve blockade; It is seen as local vasodilation, increased local blood flow, some increase in skin temperature and loss of sensation in the extremity due to the blockage of sympathetic fibers. It can be a guide in determining the effectiveness of the block because it is noninvasive and easy, providing rapid evaluation, without requiring patient cooperation to evaluate the success of the block.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infraclavicular Group | – | Device: Perfusion IndexBlock Characteristics of Ultrasound Guided Infraclavicular Block with the Perfusion Index |
| Costoclavicular Group | – | Device: Perfusion IndexBlock Characteristics of Ultrasound Guided costoclavicular Block with the Perfusion Index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All costoclavicular and infraclavicular block patients who have undergone hand,forearm and arm surgery over the age of 18
Key inclusion criteria (2 listed)
- All costoclavicular and infraclavicular block patients who have undergone hand,forearm and arm surgery
- Patients over the age of 18
Key exclusion criteria (2 listed)
- Patients who do not want to participate in the study
- Patients whose peripheral block administration is contraindicated
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 |
|---|---|---|
| Perfusion Indexperfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients | Device | Costoclavicular Group, Infraclavicular Group |
Primary outcome
Correlation of perfusion index with infraclavicular and costoclavicular block success
Time frame: 3 Months
Correlation of perfusion index with infraclavicular and costoclavicular block success
1 secondary outcome
Comparison of the Block Characteristics of Ultrasound Guided Costoclavicular and Infraclavicular Block
Time frame: 3 Months
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 Sep 2021.
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.
Busra Serce, MD study director
KCU Izmir Atatürk Training And Research Hospital
Derya Yurtlu, MD principal investigator
KCU Izmir Atatürk Training And Research Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Costoclavicular and Infraclavicular Block for Patients Who Have Undergone Hand,Forearm and Arm Surgery, run by Izmir Ataturk Training and Research Hospital at 2 sites 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 2 inclusion and 2 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 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Correlation of perfusion index with infraclavicular and costoclavicular block success (time frame: 3 Months). 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 Sep 2021.