Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade

Study Overview
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Brief Summary
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Assessement of a new approach of an ultrasound guided brachial plexus blockade between the infraclavicular and axillary area.

Detailed Description
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After an assessement of this new approach of ultrasounded-guided brachial plexus blockade in cadavers, the aim of this human study was to asssess the validity of this method in humans. The probe will be disposed on the shoulder, and the brachial plexus will be seeked below the deltoid, lateral to the major pectoralis muscle and in the vicinity of the brachial artery. At this area, an ultrasounded guided needle was inserted with an in-plane direction towards the brachial artery and local anesthetics was disposed all around the artery, without puncturing the differents nerves. Regional blockade will be evaluated by measuring onset and duation time for sensitive and motor blockade, effectiveness of this blockade, patient's confort during the procedure, ease of the procedure for practitionner, quality of ultrasound image's interpretation before and after injection.

Official Title
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Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade, Located Between the Infraclavicular and the Axillary Site

Conditions
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Nerve Block

Intervention / Treatment
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* Procedure: Ultrasound guided brachial plexus blockade
* Drug: local anaesthetic injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arm surgery performed under axillary blockade Exclusion Criteria: Local anesthetics allergy Coagulation disorder History of chronic pain Drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Descriptive study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients undergoing this new block<br>Descriptive study about the effectiveness and the feasability of this new approach of te ultrasound guided brachial plexus blockade | Procedure: Ultrasound guided brachial plexus blockade<br>* Ultrasound probe disposed on the shoulder, on the deltoid muscle. in plane puncture toward the brachial artery and injection of local anaesthetics around the brachial artery<br>Drug: local anaesthetic injection<br>* Local anesthetic injection (ropivacaine) at this new site<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of block realisation assessed by number of abandonned block | Difficulty in the block realisation (block abandonned before or during realisation) | Immediately after procedure | 
| Efficience of the block assessed by number of block sufficient for surgery | Is the block enough for surgery or must be completed | Immediately after procedure | 
| Comfort during block realization assessed by Numeric Rating Scale (NRS - 0 = No pain, 10 = worse pain) | Evaluation of comfort during block realization | Immediately after procedure | 
| Evaluation of motor block for the median nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the median nerve | 5 minutes post injection | 
| Evaluation of motor block for the median nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the median nerve | 10 minutes post injection | 
| Evaluation of motor block for the median nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the median nerve | 15 minutes post injection | 
| Evaluation of motor block for the median nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the median nerve | 20 minutes post injection | 
| Evaluation of motor block for the ulnar nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the ulnar nerve | 5 minutes post injection | 
| Evaluation of motor block for the ulnar nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the ulnar nerve | 10 minutes post injection | 
| Evaluation of motor block for the ulnar nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the ulnar nerve | 15 minutes post injection | 
| Evaluation of motor block for the ulnar nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the ulnar nerve | 20 minutes post injection | 
| Evaluation of motor block for the radial nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the radial nerve | 5 minutes post injection | 
| Evaluation of motor block for the radial nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the radial nerve | 10 minutes post injection | 
| Evaluation of motor block for the radial nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the radial nerve | 15 minutes post injection | 
| Evaluation of motor block for the radial nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the radial nerve | 20 minutes post injection | 
| Evaluation of motor block for the musculocutaneous nerve at 5 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the musculocutaneous nerve | 5 minutes post injection | 
| Evaluation of motor block for the musculocutaneous nerve at 10 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the musculocutaneous nerve | 10 minutes post injection | 
| Evaluation of motor block for the musculocutaneous nerve at 15 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the musculocutaneous nerve | 15 minutes post injection | 
| Evaluation of motor block for the musculocutaneous nerve at 20 minutes post injection assessed by a scale of motor function (0 = Complete paresis, 1 = Partial paresis, 2 = Normal motion) | Evaluation of motor block for the musculocutaneous nerve | 20 minutes post injection | 
| Evaluation of sensitive block for the median nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibility, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the median nerve at 5 minutes post injection | 5 minutes post injection | 
| Evaluation of sensitive block for the median nerve at 10 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the median nerve at 10 minutes post injection | 10 minutes post injection | 
| Evaluation of sensitive block for the median nerve at 15 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the median nerve at 15 minutes post injection | 15 minutes post injection | 
| Evaluation of sensitive block for the median nerve at 20 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the median nerve at 20 minutes post injection | 20 minutes post injection | 
| Evaluation of sensitive block for the ulnar nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the ulnar nerve at 5 minutes post injection | 5 minutes post injection | 
| Evaluation of sensitive block for the ulnar nerve at 10 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the ulnar nerve at 10 minutes post injection | 10 minutes post injection | 
| Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection | 15 minutes post injection | 
| Evaluation of sensitive block for the ulnar nerve at 20 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the ulnar nerve at 20 minutes post injection | 20 minutes post injection | 
| Evaluation of sensitive block for the radial nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the radial nerve at 5 minutes post injection | 5 minutes post injection | 
| Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection | 15 minutes post injection | 
| Evaluation of sensitive block for the musculocutaneous nerve at 5 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | valuation of sensitive block for the musculocutaneous nerve at 5 minutes post injection | 5 minutes post injection | 
| Evaluation of sensitive block for the musculocutaneous nerve at 10 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the musculocutaneous nerve at 10 minutes post injection | 10 minutes post injection | 
| Evaluation of sensitive block for the musculocutaneous nerve at 15 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the musculocutaneous nerve at 15 minutes post injection | 15 minutes post injection | 
| Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection assessed by a scale of sensitive function (0 = No sensibilityto cold, 1 = partial insensibility to cold, 2 = Normal sensation to cold) | Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection | 20 minutes post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data AGE | Age of the patient | At the time of the procedure | 
| Demographic data WEIGHT | Weight of the patient | At the time of the procedure | 
| Demographic data HEIGHT | Height of the patient | At the time of the procedure | 
| Type of surgery | hand surgery on bone/tendon/ligament/skin/nerve | At the time of the procedure | 
| Tourniquet | Time of tourniquet during surgery | At the time of the procedure | 
| Type of hospitalization | One or more day hospitalization | At the time of the procedure | 
| Local anesthetics used | Amount of local anesthetics used | At the time of the procedure | 
| Operator impression | Impression of the difficulty for the operator to perform the block | At the time of the procedure | 
| Incident during block performance | Incidence during block performance | At the time of the procedure | 
| Duration of block performance | Time of block performance | At the time of the procedure | 
| Duration of motor block | duration of motor block | from 0 to day 1 | 
| Duration of sensitive block | duration of sensitive block | from 0 to day 1 | 
| Block injury | Neuropathy or other secondary effect post block during 7 days | From day 0 to day 7 | 
| Comparative image axillary and novel point of puncture | Number of halo separating artery from different nerves at this novel level and at the axillary level | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Regional anesthesia, Ultrasound guided brachial plexus blockade, Local anesthetics : Ropivacaine