- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352333
Parasagittal Vs Cornerpocket Approaches
Parasagittal Vs Cornerpocket Approaches for Ultrasound Guided Supraclavicular Brachial Plexus Block A Comparative Study
Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.
Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.
Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .
A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.
The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .
A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After approval of research ethics committee of Sohag University hospital, a written consent will be taken from all participants to use their data for research and educational purposes The study will be carried on 80 participants who undergo elective upper limb surgery for a comparative study.
In this study the investigators will use A 22 G Spinal needle , a high frequency linear probe of US and 2 % lidocaine and 0.5% bupivacaine as local anathetics ,Every participant will be informed about advantages and disadvantages of the research and has the right to withdraw at any stage without negative impact on medical service production.
For both types of block:
Wide bored cannula is inserted,Monitoring is applied (pulse,Ecg,Bp) Oxygen mask 5 liters , Participants were positioned supine with the head turned to the non-operative Side ( contralateral side), and a pillow under the head and shoulder with the ipsilateral arm placed adducted by the patient side.
After that we sterilize the skin and apply a local anesthetic (2-3 ml of2% lidocaine).
The total volume of the local anesthetic mixture was 30 ml (10 ml of 2% lidocaine mixed with 20 ml of 0.5% bupivacine ) Then participants will be divided randomly into 2 groups ,each group 40 participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nada t Ahmed, resident
- Phone Number: 01069459544
- Email: nada_abdelrohman@yahoo.com
Study Contact Backup
- Name: Wael A Mahmoud, assistant professor
- Phone Number: 01020363508
Study Locations
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Sohag, Egypt
- Sohag University Hospital
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Contact:
- Magdy M Amin, Professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 60 years old
- ASA grade I to II
- Elective upper limb surgery
Exclusion Criteria:
- Patient refusal.
- Patient with neurological deficit in the limb of surgery
- Patients with psychiatric disease.
- Coagulopathy.
- Morbid obesity.
- Known allergy to used local anathetics
- Local infection at the block site.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group A
Cornerpocket supraclavicular ultrasound guided brachial plexus block
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two approaches of ultrasound guided supraclavicular brachial plexus block in upper limb surgery : the cornerpocket supraclavicular brachial plexus block and parasagittal supraclavicular brachial plexus block
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Active Comparator: group B
Parasagital supraclavicular ultrasound guided brachial plexus block
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two approaches of ultrasound guided supraclavicular brachial plexus block in upper limb surgery : the cornerpocket supraclavicular brachial plexus block and parasagittal supraclavicular brachial plexus block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Needle visibility in both approaches
Time Frame: 1 year
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Measure the visibility of the needles in the ultrasound
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of sensory and motor block
Time Frame: 1 year
|
Measure the time of sensory and motor block start to happen after injecting local anathetics
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1 year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate
Time Frame: 1 year
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Measrue number of failed and successful nerve blocks
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1 year
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Complications
Time Frame: 1 year
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Measure complications of the block
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1 year
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Duggan E, El Beheiry H, Perlas A, Lupu M, Nuica A, Chan VW, Brull R. Minimum effective volume of local anesthetic for ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 May-Jun;34(3):215-8. doi: 10.1097/AAP.0b013e31819a9542.
- Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.
- Choi S, McCartney CJ. Evidence Base for the Use of Ultrasound for Upper Extremity Blocks: 2014 Update. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):242-50. doi: 10.1097/AAP.0000000000000155.
- Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Parasagittal Vs Cornerpocket
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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