Brachial Plexus BlockNCT05187988
Comparative Study Between Two Different Approaches of Brachial Plexus Block: Supraclavicular Approach and Retroclavicular Approach
A study testing supraclavicular brachial plexus block and Retroclavicular brachial plexus block in people with Brachial Plexus Block, run by Sohag University at 1 site in Egypt.
Trial summary
In this study investigators will compare two different approaches of brachial plexus block ;supraclavicular approach and retroclavicular approach regarding success rate, duration of block, complications Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Block
- What is being tested?
- supraclavicular brachial plexus block and Retroclavicular brachial plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2022to 5 Sep 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 100 patients doing distal arm surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.
Who cannot join
- Patient refusal .
- local infection or deformity at the block site.
- Patient with significant neurological , psychiatric or neuromuscular disease.
- Pregnancy or lactating women .
- Coagulopathy .
- Morbid obesity .
- History of allergy to local anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
In this study investigators will compare two different approaches of brachial plexus block ;supraclavicular approach and retroclavicular approach regarding success rate, duration of block, complications
- Conditions
- Brachial Plexus Block
- Being tested
- supraclavicular brachial plexus block, Retroclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supraclavicular brachial plexus blockProcedure or surgery
group will receive brachial plexus block above clavicle,Injection of anaesthetic will be done in brachial plexus around subclavian artery
Retroclavicular brachial plexus blockProcedure or surgery
group will receive brachial plexus block inferior to the clavicle,injection of anaesthetic will be done around axillary artery
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular approach group | Active comparator | probe placed firmly over the supraclavicular fossa, parallel to the clavicle to obtain a short-axis view of the divisions of the brachial plexus and the subclavian artery, lying on the first rib After skin infiltration with lidocaine 2% a 23-gauge 70mm block needle inserted in-plane with the ultrasound beam, in a lateral-to-medial direction, until the needle tip's positioned at the junction of the first rib and subclavian artery Receives: Procedure: supraclavicular brachial plexus block |
| Retroclavicular approach group | Active comparator | the probe will be placed below and perpendicular to the clavicle, in a paramedian sagittal plane, medial to the coracoid process, to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will be then inserted in the supraclavicular fossa, approximately 1 cm posteriorly to the clavicle, and advanced in plane and strictly parallel to the ultrasound transducer. After passing the initial blind zone of about 2 cm caused by the acoustic shadow of the clavicle, the needle tip is constantly seen, until it is positioned posterior to the axillary artery Receives: Procedure: Retroclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success rate
Investigator will compare success rate of both types of block and which one is more likely to be successfully administrated
Measured: one year
Complications
Investigators will compare complications like pneumothorax,nerve injury,bleeding and which one is more likely to cause complications
Measured: one year
Duration of sensory and motor blockade
Time which each procedure will take to block sensory and motor stimuli
Measured: one year
Secondary outcomes (2)
Duration of procedure
Time which took the investigator to administrate each type of block
Measured: one year
Number of needle passes
number of times in which needle has entered been entered into the participant in each group
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start5 Jan 2022
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus BlockStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Adel Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187988
- Sponsor's protocol ID
- Soh-Med-21-11-02
- Status last verified
- Sep 2022
- First submitted
- 28 Nov 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Albrecht E, Mermoud J, Fournier N, Kern C, Kirkham KR. A systematic review of ultrasound-guided methods for brachial plexus blockade. Anaesthesia. 2016 Feb;71(2):213-27. doi: 10.1111/anae.13347. Epub 2015 Dec 16.
PubMed 26670119Yazer MS, Finlayson RJ, Tran DQ. A randomized comparison between infraclavicular block and targeted intracluster injection supraclavicular block. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):11-5. doi: 10.1097/AAP.0000000000000193.
PubMed 25478758Charbonneau J, Frechette Y, Sansoucy Y, Echave P. The Ultrasound-Guided Retroclavicular Block: A Prospective Feasibility Study. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):605-9. doi: 10.1097/AAP.0000000000000284.
PubMed 26222346Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
PubMed 30857608
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Two Different Approaches of Brachial Plexus Block: Supraclavicular Approach and Retroclavicular Approach
- ClinicalTrials.gov ID
- NCT05187988
- Acronym / sponsor ID
- Soh-Med-21-11-02
- Conditions
- Brachial Plexus Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 12 Jan 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.
In this study investigators will compare two different approaches of brachial plexus block ;supraclavicular approach and retroclavicular approach regarding success rate, duration of block, complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular approach group | Active comparator | Procedure: supraclavicular brachial plexus blockprobe placed firmly over the supraclavicular fossa, parallel to the clavicle to obtain a short-axis view of the divisions of the brachial plexus and the subclavian artery, lying on the first rib After skin infiltration with lidocaine 2% a 23-gauge 70mm block needle inserted in-plane with the ultrasound beam, in a lateral-to-medial direction, until the needle tip's positioned at the junction of the first rib and subclavian artery |
| Retroclavicular approach group | Active comparator | Procedure: Retroclavicular brachial plexus blockthe probe will be placed below and perpendicular to the clavicle, in a paramedian sagittal plane, medial to the coracoid process, to obtain a short-axis view of the cords of the brachial plexus and the axillary vessels. The needle will be then inserted in the supraclavicular fossa, approximately 1 cm posteriorly to the clavicle, and advanced in plane and strictly parallel to the ultrasound transducer. After passing the initial blind zone of about 2 cm caused by the acoustic shadow of the clavicle, the needle tip is constantly seen, until it is positioned posterior to the axillary artery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 100 patients doing distal arm surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.
Key exclusion criteria (7 listed)
- Patient refusal .
- local infection or deformity at the block site.
- Patient with significant neurological , psychiatric or neuromuscular disease.
- Pregnancy or lactating women .
- 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 |
|---|---|---|
| supraclavicular brachial plexus blockgroup will receive brachial plexus block above clavicle,Injection of anaesthetic will be done in brachial plexus around subclavian artery | Procedure or surgery | Supraclavicular approach group |
| Retroclavicular brachial plexus blockgroup will receive brachial plexus block inferior to the clavicle,injection of anaesthetic will be done around axillary artery | Procedure or surgery | Retroclavicular approach group |
Primary outcome
Block success rate
Time frame: one year
Investigator will compare success rate of both types of block and which one is more likely to be successfully administrated
Complications
Time frame: one year
Investigators will compare complications like pneumothorax,nerve injury,bleeding and which one is more likely to cause complications
Duration of sensory and motor blockade
Time frame: one year
Time which each procedure will take to block sensory and motor stimuli
2 secondary outcomes
Duration of procedure
Time frame: one year
Number of needle passes
Time frame: one year
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 8 Sep 2022.
- Background: PubMed 26670119Albrecht E, Mermoud J, Fournier N, Kern C, Kirkham KR. A systematic review of ultrasound-guided methods for brachial plexus blockade. Anaesthesia. 2016 Feb;71(2):213-27. doi: 10.1111/anae.13347. Epub 2015 Dec 16.
- Background: PubMed 25478758Yazer MS, Finlayson RJ, Tran DQ. A randomized comparison between infraclavicular block and targeted intracluster injection supraclavicular block. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):11-5. doi: 10.1097/AAP.0000000000000193.
- Background: PubMed 26222346Charbonneau J, Frechette Y, Sansoucy Y, Echave P. The Ultrasound-Guided Retroclavicular Block: A Prospective Feasibility Study. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):605-9. doi: 10.1097/AAP.0000000000000284.
- Background: PubMed 30857608Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
- Individual participant dataSharing planned: Yes
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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 supraclavicular brachial plexus block and Retroclavicular brachial plexus block in people with Brachial Plexus Block, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 7 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 8 Sep 2022. 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 Egypt. 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?
Block success rate (time frame: one year). The study lists 3 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 NCT05187988, which also lists 4 linked publications.
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 8 Sep 2022.