- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187988
Comparative Study Between Two Different Approaches of Brachial Plexus Block: Supraclavicular Approach and Retroclavicular Approach
September 4, 2022 updated by: Mahmoud Adel Mahmoud, Sohag University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sohag, Egypt
- Sohag University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 100 patients doing distal arm surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Supraclavicular approach group
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
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group will receive brachial plexus block above clavicle,Injection of anaesthetic will be done in brachial plexus around subclavian artery
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Active Comparator: Retroclavicular approach group
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
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group will receive brachial plexus block inferior to the clavicle,injection of anaesthetic will be done around axillary artery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Block success rate
Time Frame: one year
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Investigator will compare success rate of both types of block and which one is more likely to be successfully administrated
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one year
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Complications
Time Frame: one year
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Investigators will compare complications like pneumothorax,nerve injury,bleeding and which one is more likely to cause complications
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one year
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Duration of sensory and motor blockade
Time Frame: one year
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Time which each procedure will take to block sensory and motor stimuli
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one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of procedure
Time Frame: one year
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Time which took the investigator to administrate each type of block
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one year
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Number of needle passes
Time Frame: one year
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number of times in which needle has entered been entered into the participant in each group
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Grape 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.
- Charbonneau 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.
- Yazer 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2022
Primary Completion (Actual)
September 5, 2022
Study Completion (Actual)
September 5, 2022
Study Registration Dates
First Submitted
November 28, 2021
First Submitted That Met QC Criteria
January 7, 2022
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
September 8, 2022
Last Update Submitted That Met QC Criteria
September 4, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-21-11-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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