Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade
- Conditions
- Nerve Block
- Interventions
- Procedure: Ultrasound guided brachial plexus blockadeDrug: local anaesthetic injection
- Registration Number
- NCT03653000
- Lead Sponsor
- University of Liege
- Brief Summary
Assessement of a new approach of an ultrasound guided brachial plexus blockade between the infraclavicular and axillary area.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Arm surgery performed under axillary blockade
- Local anesthetics allergy
- Coagulation disorder
- History of chronic pain
- Drug or alcohol abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients undergoing this new block Ultrasound guided brachial plexus blockade Descriptive study about the effectiveness and the feasability of this new approach of te ultrasound guided brachial plexus blockade Patients undergoing this new block local anaesthetic injection Descriptive study about the effectiveness and the feasability of this new approach of te ultrasound guided brachial plexus blockade
- Primary Outcome Measures
Name Time Method 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) 10 minutes post injection Evaluation of motor block for the median nerve
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) 10 minutes post injection Evaluation of motor block for the radial nerve
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) 5 minutes post injection Evaluation of sensitive block for the median nerve at 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) 10 minutes post injection Evaluation of sensitive block for the median nerve at 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) 15 minutes post injection Evaluation of sensitive block for the median nerve at 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) 20 minutes post injection Evaluation of sensitive block for the median nerve at 20 minutes post injection
Efficience of the block assessed by number of block sufficient for surgery Immediately after procedure Is the block enough for surgery or must be completed
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) 5 minutes post injection Evaluation of motor block for the median nerve
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) 20 minutes post injection Evaluation of motor block for the median nerve
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) 10 minutes post injection Evaluation of motor block for the ulnar nerve
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) 15 minutes post injection Evaluation of motor block for the ulnar nerve
Feasibility of block realisation assessed by number of abandonned block Immediately after procedure Difficulty in the block realisation (block abandonned before or during realisation)
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) 15 minutes post injection Evaluation of motor block for the median nerve
Comfort during block realization assessed by Numeric Rating Scale (NRS - 0 = No pain, 10 = worse pain) Immediately after procedure Evaluation of comfort during block realization
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) 20 minutes post injection Evaluation of motor block for the ulnar nerve
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) 5 minutes post injection Evaluation of motor block for the ulnar nerve
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) 10 minutes post injection Evaluation of motor block for the musculocutaneous nerve
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) 5 minutes post injection Evaluation of motor block for the radial nerve
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) 15 minutes post injection Evaluation of motor block for the radial nerve
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) 20 minutes post injection Evaluation of motor block for the radial nerve
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) 5 minutes post injection Evaluation of motor block for the musculocutaneous nerve
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) 15 minutes post injection Evaluation of motor block for the musculocutaneous nerve
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) 20 minutes post injection Evaluation of motor block for the musculocutaneous nerve
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) 5 minutes post injection Evaluation of sensitive block for the ulnar nerve at 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) 10 minutes post injection Evaluation of sensitive block for the ulnar nerve at 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) 15 minutes post injection Evaluation of sensitive block for the ulnar nerve at 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) 20 minutes post injection Evaluation of sensitive block for the ulnar nerve at 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) 5 minutes post injection Evaluation of sensitive block for the radial nerve at 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) 15 minutes post injection Evaluation of sensitive block for the ulnar nerve at 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) 5 minutes post injection valuation of sensitive block for the musculocutaneous nerve at 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) 10 minutes post injection Evaluation of sensitive block for the musculocutaneous nerve at 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) 15 minutes post injection Evaluation of sensitive block for the musculocutaneous nerve at 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) 20 minutes post injection Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection
- Secondary Outcome Measures
Name Time Method Demographic data AGE At the time of the procedure Age of the patient
Demographic data WEIGHT At the time of the procedure Weight of the patient
Demographic data HEIGHT At the time of the procedure Height of the patient
Type of surgery At the time of the procedure hand surgery on bone/tendon/ligament/skin/nerve
Tourniquet At the time of the procedure Time of tourniquet during surgery
Type of hospitalization At the time of the procedure One or more day hospitalization
Local anesthetics used At the time of the procedure Amount of local anesthetics used
Operator impression At the time of the procedure Impression of the difficulty for the operator to perform the block
Incident during block performance At the time of the procedure Incidence during block performance
Duration of block performance At the time of the procedure Time of block performance
Duration of motor block from 0 to day 1 duration of motor block
Duration of sensitive block from 0 to day 1 duration of sensitive block
Block injury From day 0 to day 7 Neuropathy or other secondary effect post block during 7 days
Comparative image axillary and novel point of puncture During the procedure Number of halo separating artery from different nerves at this novel level and at the axillary level
Trial Locations
- Locations (2)
Guntz Emmanuel
🇧🇪Braine-l'Alleud, Brabant Wallon, Belgium
Lecoq Jean-Pierre
🇧🇪Liège, Liege, Belgium