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

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03653000
• Other study ID #: 123
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2022
• Source: University of Liege
• Contact: Jean-Pierre H Lecoq, MD, PhD
• Phone: 42844096
• Email: jplecoq[@]chu.ulg.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Arm surgery performed under axillary blockade

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Nerve Block

Intervention

Procedure:
• Ultrasound guided brachial plexus blockade
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

Drug:
• local anaesthetic injection
Local anesthetic injection (ropivacaine) at this new site

Locations

Country	Name	City	State
Belgium	Guntz Emmanuel	Braine-l'Alleud	Brabant Wallon
Belgium	Lecoq Jean-Pierre	Liège	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of block realisation assessed by number of abandonned block	Difficulty in the block realisation (block abandonned before or during realisation)	Immediately after procedure
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Demographic data AGE	Age of the patient	At the time of the procedure
Secondary	Demographic data WEIGHT	Weight of the patient	At the time of the procedure
Secondary	Demographic data HEIGHT	Height of the patient	At the time of the procedure
Secondary	Type of surgery	hand surgery on bone/tendon/ligament/skin/nerve	At the time of the procedure
Secondary	Tourniquet	Time of tourniquet during surgery	At the time of the procedure
Secondary	Type of hospitalization	One or more day hospitalization	At the time of the procedure
Secondary	Local anesthetics used	Amount of local anesthetics used	At the time of the procedure
Secondary	Operator impression	Impression of the difficulty for the operator to perform the block	At the time of the procedure
Secondary	Incident during block performance	Incidence during block performance	At the time of the procedure
Secondary	Duration of block performance	Time of block performance	At the time of the procedure
Secondary	Duration of motor block	duration of motor block	from 0 to day 1
Secondary	Duration of sensitive block	duration of sensitive block	from 0 to day 1
Secondary	Block injury	Neuropathy or other secondary effect post block during 7 days	From day 0 to day 7
Secondary	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