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

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

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

Study Overview

• Status: Recruiting
• Conditions: Nerve Block
• Intervention / Treatment: Procedure: Ultrasound guided brachial plexus blockade; Drug: local anaesthetic injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Pierre H Lecoq, MD, PhD; Phone Number: 32 42844096; Email: jplecoq@chu.ulg.ac.be

Study Locations

• Belgium
  • Brabant Wallon
    • Braine-l'Alleud, Brabant Wallon, Belgium, 1420
      • Recruiting
      • Guntz Emmanuel
      • Contact: Guntz Emmanuel, MD; Phone Number: 0032 023890211; Email: eguntz@ulb.ac.be
  • Liege
    • Liège, Liege, Belgium, 4000
      • Recruiting
      • Lecoq Jean-Pierre
      • Contact: Lecoq H Jean-Pierre, MD; Phone Number: 0032 043667180; Email: jplecoq@chu.ulg.ac.be
      • Contact: Lecoq H jplecoq@chu.ulg.ac.be, MD; Phone Number: 0032 043667180; Email: jplecoq@chu.ulg.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Arm surgery performed under axillary blockade

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients undergoing this new block; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Regional anesthesia; Local anesthetics : Ropivacaine; Ultrasound guided brachial plexus blockade
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 123 (Giresun University Scientific Research Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No