Nerve BlockNCT03653000
Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade
A study testing Ultrasound guided brachial plexus blockade and local anaesthetic injection in people with Nerve Block, run by University of Liege at 2 sites in Belgium.
Trial summary
Assessement of a new approach of an ultrasound guided brachial plexus blockade between the infraclavicular and axillary area. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nerve Block
- What is being tested?
- Ultrasound guided brachial plexus blockade and local anaesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Apr 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arm surgery performed under axillary blockade
Who cannot join
- Local anesthetics allergy
- Coagulation disorder
- History of chronic pain
- Drug or alcohol abuse
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Guntz Emmanuel
Braine-l'Alleud, Brabant Wallon, 1420
Guntz Emmanuel, MD, 023890211 ext. 0032, eguntz@ulb.ac.be
- Recruiting
Lecoq Jean-Pierre
Liège, Liege, 4000
Lecoq H Jean-Pierre, MD, 043667180 ext. 0032, jplecoq@chu.ulg.ac.be
Lecoq H jplecoq@chu.ulg.ac.be, MD, 043667180 ext. 0032, jplecoq@chu.ulg.ac.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Nerve Block
- Being tested
- Ultrasound guided brachial plexus blockade, local anaesthetic injection
- Keywords
- Regional anesthesia, Ultrasound guided brachial plexus blockade, Local anesthetics : Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided brachial plexus blockadeProcedure or surgery
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 anaesthetic injectionDrug
Local anesthetic injection (ropivacaine) at this new site
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Ultrasound guided brachial plexus blockade; Drug: local anaesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of block realisation assessed by number of abandonned block
Difficulty in the block realisation (block abandonned before or during realisation)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 20 minutes post injection
Secondary outcomes (14)
Demographic data AGE
Age of the patient
Measured: At the time of the procedure
Demographic data WEIGHT
Weight of the patient
Measured: At the time of the procedure
Demographic data HEIGHT
Height of the patient
Measured: At the time of the procedure
Type of surgery
hand surgery on bone/tendon/ligament/skin/nerve
Measured: At the time of the procedure
Tourniquet
Time of tourniquet during surgery
Measured: At the time of the procedure
Type of hospitalization
One or more day hospitalization
Measured: At the time of the procedure
Local anesthetics used
Amount of local anesthetics used
Measured: At the time of the procedure
Operator impression
Impression of the difficulty for the operator to perform the block
Measured: At the time of the procedure
Incident during block performance
Incidence during block performance
Measured: At the time of the procedure
Duration of block performance
Time of block performance
Measured: At the time of the procedure
Duration of motor block
duration of motor block
Measured: from 0 to day 1
Duration of sensitive block
duration of sensitive block
Measured: from 0 to day 1
Block injury
Neuropathy or other secondary effect post block during 7 days
Measured: 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
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Apr 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J P Lecoq, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653000
- Sponsor's protocol ID
- 123
- Status last verified
- Jun 2022
- First submitted
- 27 Jul 2018
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing data
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessement of a Novel Approach to Ultrasound-guided Brachial Plexus Blockade, Located Between the Infraclavicular and the Axillary Site
- ClinicalTrials.gov ID
- NCT03653000
- Acronym / sponsor ID
- 123
- Conditions
- Nerve Block
- Keywords
- Regional anesthesia, Ultrasound guided brachial plexus blockade, Local anesthetics : Ropivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive study
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing this new block | Experimental | Procedure: Ultrasound guided brachial plexus blockade, Drug: local anaesthetic injectionDescriptive study about the effectiveness and the feasability of this new approach of te ultrasound guided brachial plexus blockade |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Arm surgery performed under axillary blockade
Key exclusion criteria (4 listed)
- Local anesthetics allergy
- Coagulation disorder
- History of chronic pain
- Drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided brachial plexus blockadeUltrasound 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 | Procedure or surgery | Patients undergoing this new block |
| local anaesthetic injectionLocal anesthetic injection (ropivacaine) at this new site | Drug | Patients undergoing this new block |
Primary outcome
Feasibility of block realisation assessed by number of abandonned block
Time frame: Immediately after procedure
Difficulty in the block realisation (block abandonned before or during realisation)
Efficience of the block assessed by number of block sufficient for surgery
Time frame: Immediately after procedure
Is 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)
Time frame: Immediately after procedure
Evaluation 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)
Time frame: 5 minutes post injection
Evaluation 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)
Time frame: 10 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation 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)
Time frame: 20 minutes post injection
Evaluation 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)
Time frame: 5 minutes post injection
Evaluation 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)
Time frame: 10 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation 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)
Time frame: 20 minutes post injection
Evaluation 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)
Time frame: 5 minutes post injection
Evaluation 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)
Time frame: 10 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation 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)
Time frame: 20 minutes post injection
Evaluation 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)
Time frame: 5 minutes post injection
Evaluation 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)
Time frame: 10 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation of motor block for the musculocutaneous nerve
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)
Time frame: 20 minutes post injection
Evaluation 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)
Time frame: 5 minutes post injection
Evaluation 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)
Time frame: 10 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation 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)
Time frame: 20 minutes post injection
Evaluation 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)
Time frame: 5 minutes post injection
Evaluation 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)
Time frame: 10 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation 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)
Time frame: 20 minutes post injection
Evaluation 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)
Time frame: 5 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation 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)
Time frame: 5 minutes post injection
valuation 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)
Time frame: 10 minutes post injection
Evaluation 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)
Time frame: 15 minutes post injection
Evaluation of sensitive block for the musculocutaneous nerve at 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)
Time frame: 20 minutes post injection
Evaluation of sensitive block for the musculocutaneous nerve at 20 minutes post injection
14 secondary outcomes
Demographic data AGE
Time frame: At the time of the procedure
Demographic data WEIGHT
Time frame: At the time of the procedure
Demographic data HEIGHT
Time frame: At the time of the procedure
Type of surgery
Time frame: At the time of the procedure
Tourniquet
Time frame: At the time of the procedure
Type of hospitalization
Time frame: At the time of the procedure
Local anesthetics used
Time frame: At the time of the procedure
Operator impression
Time frame: At the time of the procedure
Incident during block performance
Time frame: At the time of the procedure
Duration of block performance
Time frame: At the time of the procedure
Duration of motor block
Time frame: from 0 to day 1
Duration of sensitive block
Time frame: from 0 to day 1
Block injury
Time frame: From day 0 to day 7
Comparative image axillary and novel point of puncture
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No. No sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided brachial plexus blockade and local anaesthetic injection in people with Nerve Block, run by University of Liege at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Pierre H Lecoq, MD, PhD (42844096 ext. 32, jplecoq@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of block realisation assessed by number of abandonned block (time frame: Immediately after procedure). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.