Clinical trial NCT03653000: Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade
Official title: Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade, Located Between the Infraclavicular and the Axillary Site
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Keywords: Regional anesthesia
Ultrasound guided brachial plexus blockade
Local anesthetics : Ropivacaine
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Descriptive study
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Arm surgery performed under axillary blockade

Exclusion Criteria:

* Local anesthetics allergy
* Coagulation disorder
* History of chronic pain
* Drug or alcohol abuse

Primary outcomes:
measure: Feasibility of block realisation assessed by number of abandonned block
timeFrame: Immediately after procedure
measure: Efficience of the block assessed by number of block sufficient for surgery
timeFrame: Immediately after procedure
measure: Comfort during block realization assessed by Numeric Rating Scale (NRS - 0 = No pain, 10 = worse pain)
timeFrame: Immediately after procedure
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 10 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 20 minutes post injection
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 10 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 20 minutes post injection
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 10 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 20 minutes post injection
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 10 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 20 minutes post injection
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 10 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 20 minutes post injection
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 10 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 20 minutes post injection
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 5 minutes post injection
measure: 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)
timeFrame: 10 minutes post injection
measure: 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)
timeFrame: 15 minutes post injection
measure: 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)
timeFrame: 20 minutes post injection
Secondary outcomes:
measure: Demographic data AGE
timeFrame: At the time of the procedure
measure: Demographic data WEIGHT
timeFrame: At the time of the procedure
measure: Demographic data HEIGHT
timeFrame: At the time of the procedure
measure: Type of surgery
timeFrame: At the time of the procedure
measure: Tourniquet
timeFrame: At the time of the procedure
measure: Type of hospitalization
timeFrame: At the time of the procedure
measure: Local anesthetics used
timeFrame: At the time of the procedure
measure: Operator impression
timeFrame: At the time of the procedure
measure: Incident during block performance
timeFrame: At the time of the procedure
measure: Duration of block performance
timeFrame: At the time of the procedure
measure: Duration of motor block
timeFrame: from 0 to day 1
measure: Duration of sensitive block
timeFrame: from 0 to day 1
measure: Block injury
timeFrame: From day 0 to day 7
measure: Comparative image axillary and novel point of puncture
timeFrame: During the procedure
Other outcomes:
Locations:
city: Braine-l'Alleud
country: Belgium
facility: Guntz Emmanuel
state: Brabant Wallon
city: Liège
country: Belgium
facility: Lecoq Jean-Pierre
state: Liege
Study officials:
References: