NCT03653000

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2.6 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

2.7 years

First QC Date

July 27, 2018

Last Update Submit

June 20, 2022

Conditions

Nerve Block

Keywords

Regional anesthesiaUltrasound guided brachial plexus blockadeLocal anesthetics : Ropivacaine

Outcome Measures

Primary Outcomes (33)

  • 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 Outcomes (14)

  • Demographic data AGE

    At the time of the procedure

  • Demographic data WEIGHT

    At the time of the procedure

  • Demographic data HEIGHT

    At the time of the procedure

  • Type of surgery

    At the time of the procedure

  • Tourniquet

    At the time of the procedure

  • +9 more secondary outcomes

Study Arms (1)

Patients undergoing this new block

EXPERIMENTAL

Descriptive study about the effectiveness and the feasability of this new approach of te ultrasound guided brachial plexus blockade

Procedure: Ultrasound guided brachial plexus blockadeDrug: local anaesthetic injection

Interventions

Ultrasound guided brachial plexus blockadePROCEDURE

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

Patients undergoing this new block
local anaesthetic injectionDRUG

Local anesthetic injection (ropivacaine) at this new site

Patients undergoing this new block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arm surgery performed under axillary blockade

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guntz Emmanuel

Braine-l'Alleud, Brabant Wallon, 1420, Belgium

RECRUITING

Lecoq Jean-Pierre

Liège, Liege, 4000, Belgium

RECRUITING

MeSH Terms

Interventions

Anesthesia, Local

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Jean-Pierre H Lecoq, MD, PhD

CONTACT

42844096jplecoq@chu.ulg.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Descriptive study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 31, 2018

Study Start

April 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

No sharing data

Locations

BE(2)