Upper Extremity FractureNCT04748211
Effect of Infraclavicular and Interscalen Block on Oxygenitaon of the Forearm
A study testing Infraclavicular Block and Interscalen Block in people with Upper Extremity Fracture, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
to research the oxygenitaon effects of infraclavicular and interscalene blocks on the forearm. 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
- What is being tested?
- Infraclavicular Block and Interscalen Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2018to 15 Jun 2019
- 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
- aged between 18-65
- ASA Score I-III
- undergoing elective or emergency arm, elbow and forearm surgery
Who cannot join
- Patient's refusal for Brachial Plexus Blockage
- Patients who had any neurological disorders preventing the evaluation of the sensory block in the upper extremity,
- Infection in the area to be blocked with ICB or ISB,
- Non-cooperated patients
- Patients with coagulopathy,
- Morbidly obese patients
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- Patients with diabetes mellitus
- Patients with hypertension
- Patients with peripheral artery disease
- Patients with allergy to the drugsto be used
- Patients who had trauma in the area scheduled for the block
- Paitens who had deterioration of anatomical integrity because of previous surgery
- Pregnant women
- Patients whose block failed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Infraclavicular and Interscalen Block on Oxygenitaon of the Forearm : Randomized Controlled Study.
to research the oxygenitaon effects of infraclavicular and interscalene blocks on the forearm.
Read the detailed description
To research the oxygenation effects of infraclavicular and interscalen blocks on the forearm by comparing the blood flow (BF) values using the USG, Perfusion index (PI) and Near infrared spectroscopy (NIRS) values using the massimo device.
- Conditions
- Upper Extremity Fracture
- Being tested
- Infraclavicular Block, Interscalen Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular BlockProcedure or surgery
USI and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.
Interscalen BlockProcedure or surgery
USI and neurostimulator guided interscalen block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.
| Study group | Role | What they receive |
|---|---|---|
| Infraclavicular Block | Experimental | Group I received USG and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes. Receives: Procedure: Infraclavicular Block |
| Interscalen Block | Experimental | Group II received USG and neurostimulator guided interscalen block. 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes. Receives: Procedure: Interscalen Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation of the forearm
to compare the oxygenation of the forearm by measuring perfusion index device
Measured: during the procedure three times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start15 Jun 2018
- Primary completion15 Jun 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a two-arm parallel assignment. One group will receive infraclavicular block and the other will receive interscalen block
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OZCAN PISKIN, MD, Bulent Ecevit University
- Investigators
- Eren Açıkgöz, M.D., Principal investigator, Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748211
- Sponsor's protocol ID
- 2017-116-06/12
- Status last verified
- Feb 2021
- First submitted
- 13 Dec 2020
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infraclavicular and Interscalen Block on Oxygenitaon of the Forearm : Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04748211
- Acronym / sponsor ID
- 2017-116-06/12
- Conditions
- Upper Extremity Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 10 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 research the oxygenitaon effects of infraclavicular and interscalene blocks on the forearm.
Detailed description
To research the oxygenation effects of infraclavicular and interscalen blocks on the forearm by comparing the blood flow (BF) values using the USG, Perfusion index (PI) and Near infrared spectroscopy (NIRS) values using the massimo device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will be a two-arm parallel assignment. One group will receive infraclavicular block and the other will receive interscalen block
| Arm | Type | Receives |
|---|---|---|
| Infraclavicular Block | Experimental | Procedure: Infraclavicular BlockGroup I received USG and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes. |
| Interscalen Block | Experimental | Procedure: Interscalen BlockGroup II received USG and neurostimulator guided interscalen block. 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 18-65
- ASA Score I-III
- undergoing elective or emergency arm, elbow and forearm surgery
Key exclusion criteria (14 listed)
- Patient's refusal for Brachial Plexus Blockage
- Patients who had any neurological disorders preventing the evaluation of the sensory block in the upper extremity,
- Infection in the area to be blocked with ICB or ISB,
- Non-cooperated patients
- Patients with coagulopathy,
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 |
|---|---|---|
| Infraclavicular BlockUSI and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes. | Procedure or surgery | Infraclavicular Block |
| Interscalen BlockUSI and neurostimulator guided interscalen block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes. | Procedure or surgery | Interscalen Block |
Primary outcome
oxygenation of the forearm
Time frame: during the procedure three times
to compare the oxygenation of the forearm by measuring perfusion index device
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 12 Feb 2021.
- 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.
Eren Açıkgöz, M.D. principal investigator
Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraclavicular Block and Interscalen Block in people with Upper Extremity Fracture, run by 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 14 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 12 Feb 2021. 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?
oxygenation of the forearm (time frame: during the procedure three times). 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 12 Feb 2021.