- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05240729
Using Ultrasound in Infraclavicular in Upper Limb Surgeries
January 8, 2023 updated by: Rowayda Nabil gaber, Minia University
Ultrasound Guided Retroclavicular Approach Versus Costoclavicular Approach of Infraclavicular Brachial Plexus Block for Upper Limb Surgeries
Comparison of 3 approach of infraclavicular brachial plexus
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Comparison of retroclavicular & costoclavicular and classic type of infraclavicular brachial plexus block for upper limb surgeries
Study Type
Interventional
Enrollment (Actual)
60
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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Minya, Egypt, 61111
- Facutly of Medicine
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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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age: between 18 and 60 years ASA I and II BMI between 18 and 35 surgeries to forearm and hand
Exclusion Criteria:
- patient refusal pregnancy allergy to local anaesthetics local infection neuropathy ,coagulopathy anatomical abnormality in clavicular region
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: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Retroclavicular
Retroclavicular approach to the infraclavicular region, 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 then be 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 will be constantly seen, until it will be positioned posterior to the axillary artery.
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Using ultrasound in 3different techniques of infraclavicular brachial plexus block
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Active Comparator: Costoclavicular
A new approach to the infraclavicular block The ultrasound transducer will be placed parallel and inferior to the clavicle and angled cephalad to optimize the ultrasound view.
The block needle will be inserted in-plane from a lateral to medial direction into the costoclavicular space and the entire drug will be deposited in this location
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Using ultrasound in 3different techniques of infraclavicular brachial plexus block
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|
Active Comparator: Classic
Infraclavicular brachial plexus block (ICPB) ultrasound probe will be placed near the lower edge of the clavicle, and a transverse view of the subclavian artery and vein will be visualized.
Using a needle guide, the needle will be advanced under real-time ultrasound guidance, and local anaesthetic will be injected near the subclavian artery, 15 mm medially and 15 mm laterally to the artery.
The extent of sensory and motor block will be evaluated at 30 minutes after the injection
|
Using ultrasound in 3different techniques of infraclavicular brachial plexus block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor and sensory block success rate
Time Frame: 30 min
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Success rate 30 min after local anasthetic injections
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30 min
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jozef zekry, MD, Minia University
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)
May 24, 2021
Primary Completion (Actual)
February 24, 2022
Study Completion (Actual)
June 24, 2022
Study Registration Dates
First Submitted
February 6, 2022
First Submitted That Met QC Criteria
February 6, 2022
First Posted (Actual)
February 15, 2022
Study Record Updates
Last Update Posted (Estimate)
January 10, 2023
Last Update Submitted That Met QC Criteria
January 8, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 53:2021
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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