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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03653000
Enrollment
20
Registered
2018-08-31
Start date
2021-04-01
Completion date
2023-12-01
Last updated
2022-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Block

Keywords

Regional anesthesia, Ultrasound guided brachial plexus blockade, Local anesthetics : Ropivacaine

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.

Interventions

PROCEDUREUltrasound 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

Local anesthetic injection (ropivacaine) at this new site

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Descriptive study

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Arm surgery performed under axillary blockade

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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 injectionEvaluation of sensitive block for the musculocutaneous nerve at 20 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)20 minutes post injectionEvaluation of motor block for the musculocutaneous 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 injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation of sensitive block for the median nerve at 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)5 minutes post injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation 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 injectionvaluation 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 injectionEvaluation 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 injectionEvaluation of sensitive block for the musculocutaneous nerve at 15 minutes post injection
Feasibility of block realisation assessed by number of abandonned blockImmediately after procedureDifficulty in the block realisation (block abandonned before or during realisation)
Efficience of the block assessed by number of block sufficient for surgeryImmediately after procedureIs the block enough for surgery or must be completed
Comfort during block realization assessed by Numeric Rating Scale (NRS - 0 = No pain, 10 = worse pain)Immediately after procedureEvaluation of comfort during block realization
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 injectionEvaluation of motor block for the median nerve
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 injectionEvaluation of motor block for the median nerve
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 injectionEvaluation 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 injectionEvaluation of motor block for the median 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 injectionEvaluation of motor block for the ulnar 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 injectionEvaluation 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 injectionEvaluation of motor block for the ulnar nerve
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 injectionEvaluation of motor block for the ulnar 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 injectionEvaluation of motor block for the radial 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 injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation 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 injectionEvaluation of motor block for the musculocutaneous 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 injectionEvaluation 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 injectionEvaluation of motor block for the musculocutaneous nerve

Secondary

MeasureTime frameDescription
Demographic data WEIGHTAt the time of the procedureWeight of the patient
Demographic data HEIGHTAt the time of the procedureHeight of the patient
Type of surgeryAt the time of the procedurehand surgery on bone/tendon/ligament/skin/nerve
TourniquetAt the time of the procedureTime of tourniquet during surgery
Type of hospitalizationAt the time of the procedureOne or more day hospitalization
Local anesthetics usedAt the time of the procedureAmount of local anesthetics used
Operator impressionAt the time of the procedureImpression of the difficulty for the operator to perform the block
Incident during block performanceAt the time of the procedureIncidence during block performance
Duration of block performanceAt the time of the procedureTime of block performance
Duration of motor blockfrom 0 to day 1duration of motor block
Duration of sensitive blockfrom 0 to day 1duration of sensitive block
Block injuryFrom day 0 to day 7Neuropathy or other secondary effect post block during 7 days
Comparative image axillary and novel point of punctureDuring the procedureNumber of halo separating artery from different nerves at this novel level and at the axillary level
Demographic data AGEAt the time of the procedureAge of the patient

Countries

Belgium

Contacts

Primary ContactJean-Pierre H Lecoq, MD, PhD
jplecoq@chu.ulg.ac.be42844096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026