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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653000
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
J P Lecoq, University of Liege

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

Condition or disease Intervention/treatment Phase
Nerve Block Procedure: Ultrasound guided brachial plexus blockade Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Descriptive study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade, Located Between the Infraclavicular and the Axillary Site
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. Feasibility of block realisation assessed by number of abandonned block [ Time Frame: During block performance ]
    Difficulty in the block realisation (block abandonned before or during realisation)

  2. Efficience of the block assessed by number of block sufficient for surgery [ Time Frame: Before block performance ]
    Is the block enough for surgery or must be completed

  3. Comfort during block realization assessed by EVA [ Time Frame: During block performance ]
    Evaluation of comfort during block realization

  4. Evaluation of motor block for the median nerve at 5 minutes post injection assessed by a scale of motor function [ Time Frame: 5 minutes post injection ]
    Evaluation of motor block for the median nerve

  5. Evaluation of motor block for the median nerve at 10 minutes post injection assessed by a scale of motor function [ Time Frame: 10 minutes post injection ]
    Evaluation of motor block for the median nerve

  6. Evaluation of motor block for the median nerve at 15 minutes post injection assessed by a scale of motor function [ Time Frame: 15 minutes post injection ]
    Evaluation of motor block for the median nerve

  7. Evaluation of motor block for the median nerve at 20 minutes post injection assessed by a scale of motor function [ Time Frame: 20 minutes post injection ]
    Evaluation of motor block for the median nerve

  8. Evaluation of motor block for the ulnar nerve at 5 minutes post injection assessed by a scale of motor function [ Time Frame: 5 minutes post injection ]
    Evaluation of motor block for the ulnar nerve

  9. Evaluation of motor block for the ulnar nerve at 10 minutes post injection assessed by a scale of motor function [ Time Frame: 10 minutes post injection ]
    Evaluation of motor block for the ulnar nerve

  10. Evaluation of motor block for the ulnar nerve at 15 minutes post injection assessed by a scale of motor function [ Time Frame: 15 minutes post injection ]
    Evaluation of motor block for the ulnar nerve

  11. Evaluation of motor block for the ulnar nerve at 20 minutes post injection assessed by a scale of motor function [ Time Frame: 20 minutes post injection ]
    Evaluation of motor block for the ulnar nerve

  12. Evaluation of motor block for the radial nerve at 5 minutes post injection assessed by a scale of motor function [ Time Frame: 5 minutes post injection ]
    Evaluation of motor block for the radial nerve

  13. Evaluation of motor block for the radial nerve at 10 minutes post injection assessed by a scale of motor function [ Time Frame: 10 minutes post injection ]
    Evaluation of motor block for the radial nerve

  14. Evaluation of motor block for the radial nerve at 15 minutes post injection assessed by a scale of motor function [ Time Frame: 15 minutes post injection ]
    Evaluation of motor block for the radial nerve

  15. Evaluation of motor block for the radial nerve at 20 minutes post injection assessed by a scale of motor function [ Time Frame: 20 minutes post injection ]
    Evaluation of motor block for the radial nerve

  16. Evaluation of motor block for the musculocutaneous nerve at 5 minutes post injection assessed by a scale of motor function [ Time Frame: 5 minutes post injection ]
    Evaluation of motor block for the musculocutaneous nerve

  17. Evaluation of motor block for the musculocutaneous nerve at 10 minutes post injection assessed by a scale of motor function [ Time Frame: 10 minutes post injection ]
    Evaluation of motor block for the musculocutaneous nerve

  18. Evaluation of motor block for the musculocutaneous nerve at 15 minutes post injection assessed by a scale of motor function [ Time Frame: 15 minutes post injection ]
    Evaluation of motor block for the musculocutaneous nerve

  19. Evaluation of motor block for the musculocutaneous nerve at 20 minutes post injection assessed by a scale of motor function [ Time Frame: 20 minutes post injection ]
    Evaluation of motor block for the musculocutaneous nerve

  20. Evaluation of sensitive block for the median nerve at 5 minutes post injection assessed by a scale of sensitive function [ Time Frame: 5 minutes post injection ]
    Evaluation of sensitive block for the median nerve at 5 minutes post injection

  21. Evaluation of sensitive block for the median nerve at 10 minutes post injection assessed by a scale of sensitive function [ Time Frame: 10 minutes post injection ]
    Evaluation of sensitive block for the median nerve at 10 minutes post injection

  22. Evaluation of sensitive block for the median nerve at 15 minutes post injection assessed by a scale of sensitive function [ Time Frame: 15 minutes post injection ]
    Evaluation of sensitive block for the median nerve at 15 minutes post injection

  23. Evaluation of sensitive block for the median nerve at 20 minutes post injection assessed by a scale of sensitive function [ Time Frame: 20 minutes post injection ]
    Evaluation of sensitive block for the median nerve at 20 minutes post injection

  24. Evaluation of sensitive block for the ulnar nerve at 5 minutes post injection assessed by a scale of sensitive function [ Time Frame: 5 minutes post injection ]
    Evaluation of sensitive block for the ulnar nerve at 5 minutes post injection

  25. Evaluation of sensitive block for the ulnar nerve at 10 minutes post injection assessed by a scale of sensitive function [ Time Frame: 10 minutes post injection ]
    Evaluation of sensitive block for the ulnar nerve at 10 minutes post injection

  26. Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection [ Time Frame: 15 minutes post injection ]
    Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection

  27. Evaluation of sensitive block for the ulnar nerve at 20 minutes post injection assessed by a scale of sensitive function [ Time Frame: 20 minutes post injection ]
    Evaluation of sensitive block for the ulnar nerve at 20 minutes post injection

  28. Evaluation of sensitive block for the radial nerve at 5 minutes post injection assessed by a scale of sensitive function [ Time Frame: 5 minutes post injection ]
    Evaluation of sensitive block for the radial nerve at 5 minutes post injection

  29. Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection assessed by a scale of sensitive function [ Time Frame: 15 minutes post injection ]
    Evaluation of sensitive block for the ulnar nerve at 15 minutes post injection

  30. Evaluation of sensitive block for the musculocutaneous nerve at 5 minutes post injection assessed by a scale of sensitive function [ Time Frame: 5 minutes post injection ]
    valuation of sensitive block for the musculocutaneous nerve at 5 minutes post injection

  31. Evaluation of sensitive block for the musculocutaneous nerve at 10 minutes post injection assessed by a scale of sensitive function [ Time Frame: 10 minutes post injection ]
    Evaluation of sensitive block for the musculocutaneous nerve at 10 minutes post injection

  32. Evaluation of sensitive block for the musculocutaneous nerve at 15 minutes post injection assessed by a scale of sensitive function [ Time Frame: 15 minutes post injection ]
    Evaluation of sensitive block for the musculocutaneous nerve at 15 minutes post injection

  33. Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection assessed by a scale of sensitive function [ Time Frame: 20 minutes post injection ]
    Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection


Secondary Outcome Measures :
  1. Demographic data AGE [ Time Frame: Before block performance ]
    Age of the patient

  2. Demographic data WEIGHT [ Time Frame: Before block performance ]
    Weight of the patient

  3. Demographic data HEIGHT [ Time Frame: Before block performance ]
    Height of the patient

  4. Type of surgery [ Time Frame: Before block performance ]
    hand surgery on bone/tendon/ligament/skin/nerve

  5. Tourniquet [ Time Frame: During Surgery ]
    Time of tourniquet during surgery

  6. Type of hospitalization [ Time Frame: During block assessment ]
    One or more day hospitalization

  7. Local anesthetics used [ Time Frame: During block performance ]
    Amount of local anesthetics used

  8. Operator impression [ Time Frame: During block performance ]
    Impression of the difficulty for the operator to perform the block

  9. Incident during block performance [ Time Frame: During block performance ]
    Incidence during block performance

  10. Duration of block performance [ Time Frame: During block performance ]
    Time of block performance

  11. Duration of motor block [ Time Frame: from 0 to day 1 ]
    duration of motor block

  12. Duration of sensitive block [ Time Frame: from 0 to day 1 ]
    duration of sensitive block

  13. Block injury [ Time Frame: From day 0 to day 7 ]
    Neuropathy or other secondary effect post block during 7 days

  14. Comparative image axillary and novel point of puncture [ Time Frame: During bloc performance ]
    Number of halo separating artery from different nerves at this novel level and at the axillary level



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Arm surgery performed under axillary blockade

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653000


Contacts
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Contact: Jean-Pierre H Lecoq, MD, PhD 42844096 ext 32 jplecoq@chu.ulg.ac.be

Locations
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Belgium
Guntz Emmanuel
Braine-l'Alleud, Brabant Wallon, Belgium, 1420
Contact: Guntz Emmanuel, MD    023890211 ext 0032    eguntz@ulb.ac.be   
Lecoq Jean-Pierre
Liège, Liege, Belgium, 4000
Contact: Lecoq H Jean-Pierre, MD    043667180 ext 0032    jplecoq@chu.ulg.ac.be   
Contact: Lecoq H jplecoq@chu.ulg.ac.be, MD    043667180 ext 0032    jplecoq@chu.ulg.ac.be   
Sponsors and Collaborators
University of Liege

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Responsible Party: J P Lecoq, Medical Doctor, University of Liege
ClinicalTrials.gov Identifier: NCT03653000    
Other Study ID Numbers: 123
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No sharing data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by J P Lecoq, University of Liege:
Regional anesthesia
Ultrasound guided brachial plexus blockade
Local anesthetics : Ropivacaine
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs