Anesthesia, LocalNCT06158243
Description of the Brachial Plexus Block at the Humeral Head in Children: a Sono-anatomical Study
An observational study of Anesthesia, Local and Brachial Plexus; Pressure, run by Centre Hospitalier Universitaire Saint Pierre.
Trial summary
the investigators are interested in assessing the feasibility and value of brachial plexus block at the level of the humeral head in children. As a first step, the investigators propose to carry out a sono-anatomical study to describe the plexus at this level, the distribution of nerves in relation to the axillary… Read more about this study
- Who is it for?
- Ages 1 month to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local, Brachial Plexus; Pressure
- What is being tested?
- Sono-anatomical Study
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Apr 2024
- How long will I take part?
- 5 Months
- Phase
- Observational
- 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 1 month to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study will be carried out in 100 children aged 0-10, divided into 5 groups of 20: 0-2 years, 2-4 years, 4-6 years, 6-8 years and 8-10 years. After obtaining informed consent from parents, patients will be included in the study according to inclusion and exclusion criteria. Sonographic observations and measurements will be performed during narcosis, if possible, without delaying or interfering with surgery. No puncture will be performed.
Who may be able to join
- patient ASA 1-2
- aged 0 to 10 years
- scheduled surgery
- parental consent obtained
Who cannot join
- Parental refusal to participate
- suspicion of local skin infection
- inability to place the limb in the position required for sonographic examination
- Upper limb malformation
- ASA III, IV
- Major surgery (cardiac, neurosurgery...)
- emergencies
Trial locations and contacts
No sites are listed yet.
About this study
the investigators are interested in assessing the feasibility and value of brachial plexus block at the level of the humeral head in children. As a first step, the investigators propose to carry out a sono-anatomical study to describe the plexus at this level, the distribution of nerves in relation to the axillary artery, and the description of bone and muscle structures.
Read the detailed description
Brachial plexus blocks below the clavicle provide anesthesia and analgesia of the upper limb for elbow, forearm and hand surgery. Among the techniques described, axillary and costo-clavicular blocks are most frequently used.
In the axillary approach to the brachial plexus, the ulnar, median and radial nerves are in the direct vicinity of the axillary artery. However, there is considerable variability in the location of these nerves . What's more, the musculocutaneous nerve is most often distant from the other nerves of the plexus. These disadvantages are not encountered with the costo-clavicular technique, in which the nerves are brought together in the same diffusion space. On the other hand, this method does run the risk of pneumothorax and anesthesia of the phrenic nerve.
In this context, the investigators have described the brachial plexus block at the level of the humeral head in adults, which enables practicians to work on nerves gathered around the axillary artery without any risk of phrenic or pulmonary damage4.
In children, Small et al described a supra-clavicular approach, but Clayton et al, noting the high risk of pneumothorax, strongly advocated the axillary approach.
- Conditions
- Anesthesia, Local, Brachial Plexus; Pressure
- Being tested
- Sono-anatomical Study
- Keywords
- Brachial plexus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sono-anatomical StudyOther
The arm is abducted (90°), externally rotated, with the forearm flexed over the arm (90°). A linear ultrasound probe (8-15 MHz) is placed in front of the humeral head, in a sagittal plane. Location begins at axillary level, vessels, nerves and humerus are identified, and the probe is moved medially to reach and identify the humeral head.
| Study group | Role | What they receive |
|---|---|---|
| 0-2 | children aged 0 to 2 years Receives: Other: Sono-anatomical Study | |
| 2-4 | children aged 2 to 4 years | |
| 4-6 | children aged 4 to 6 years | |
| 6-8 | children aged 6 to 8 years Receives: Other: Sono-anatomical Study | |
| 8-10 | children aged 8 to 10 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of the position of the nerves around the axillary artery
Hourly distribution of nerve structures around the axillary artery , expressed in degrees and measured with a protractor
Measured: through study completion, around 5 months
Secondary outcomes (1)
distance between anatomical structures
depth of diffusion spaces Skin-cartilage distance Cartilage thickness Skin-nerve distance Skin-to-vessel distance size of nerves all these measurements in centimeters
Measured: through study completion, around 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raoul Ngatcha, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- Emmanuel GUNTZ, Study director, Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158243
- Sponsor's protocol ID
- B062023230501
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nalini KB, Bevinaguddaiah Y, Thiyagarajan B, Shivasankar A, Pujari VS. Ultrasound-guided costoclavicular vs. axillary brachial plexus block: A randomized clinical study. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):655-660. doi: 10.4103/joacp.JOACP_43_20. Epub 2021 Nov 2.
PubMed 35340944Christophe JL, Berthier F, Boillot A, Tatu L, Viennet A, Boichut N, Samain E. Assessment of topographic brachial plexus nerves variations at the axilla using ultrasonography. Br J Anaesth. 2009 Oct;103(4):606-12. doi: 10.1093/bja/aep207. Epub 2009 Aug 21.
PubMed 19700445SMALL GA. Brachial plexus block anesthesia in children. J Am Med Assoc. 1951 Dec 22;147(17):1648-51. doi: 10.1001/jama.1951.03670340038009. No abstract available.
PubMed 14880419Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566.
PubMed 28157792
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Brachial Plexus Block at the Humeral Head in Children: a Sono-anatomical Study
- ClinicalTrials.gov ID
- NCT06158243
- Acronym / sponsor ID
- B062023230501
- Conditions
- Anesthesia, Local, Brachial Plexus; Pressure
- Keywords
- Brachial plexus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
the investigators are interested in assessing the feasibility and value of brachial plexus block at the level of the humeral head in children. As a first step, the investigators propose to carry out a sono-anatomical study to describe the plexus at this level, the distribution of nerves in relation to the axillary artery, and the description of bone and muscle structures.
Detailed description
Brachial plexus blocks below the clavicle provide anesthesia and analgesia of the upper limb for elbow, forearm and hand surgery. Among the techniques described, axillary and costo-clavicular blocks are most frequently used.
In the axillary approach to the brachial plexus, the ulnar, median and radial nerves are in the direct vicinity of the axillary artery. However, there is considerable variability in the location of these nerves . What's more, the musculocutaneous nerve is most often distant from the other nerves of the plexus. These disadvantages are not encountered with the costo-clavicular technique, in which the nerves are brought together in the same diffusion space. On the other hand, this method does run the risk of pneumothorax and anesthesia of the phrenic nerve.
In this context, the investigators have described the brachial plexus block at the level of the humeral head in adults, which enables practicians to work on nerves gathered around the axillary artery without any risk of phrenic or pulmonary damage4.
In children, Small et al described a supra-clavicular approach, but Clayton et al, noting the high risk of pneumothorax, strongly advocated the axillary approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0-2 | – | Other: Sono-anatomical Studychildren aged 0 to 2 years |
| 2-4 | – | –children aged 2 to 4 years |
| 4-6 | – | –children aged 4 to 6 years |
| 6-8 | – | Other: Sono-anatomical Studychildren aged 6 to 8 years |
| 8-10 | – | –children aged 8 to 10 years |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study will be carried out in 100 children aged 0-10, divided into 5 groups of 20: 0-2 years, 2-4 years, 4-6 years, 6-8 years and 8-10 years. After obtaining informed consent from parents, patients will be included in the study according to inclusion and exclusion criteria. Sonographic observations and measurements will be performed during narcosis, if possible, without delaying or interfering with surgery. No puncture will be performed.
Key inclusion criteria (4 listed)
- patient ASA 1-2
- aged 0 to 10 years
- scheduled surgery
- parental consent obtained
Key exclusion criteria (7 listed)
- Parental refusal to participate
- suspicion of local skin infection
- inability to place the limb in the position required for sonographic examination
- Upper limb malformation
- ASA III, IV
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 |
|---|---|---|
| Sono-anatomical StudyThe arm is abducted (90°), externally rotated, with the forearm flexed over the arm (90°). A linear ultrasound probe (8-15 MHz) is placed in front of the humeral head, in a sagittal plane. Location begins at axillary level, vessels, nerves and humerus are identified, and the probe is moved medially to reach and identify the humeral head. | Other | 0-2, 6-8 |
Primary outcome
description of the position of the nerves around the axillary artery
Time frame: through study completion, around 5 months
Hourly distribution of nerve structures around the axillary artery , expressed in degrees and measured with a protractor
1 secondary outcome
distance between anatomical structures
Time frame: through study completion, around 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Background: PubMed 35340944Nalini KB, Bevinaguddaiah Y, Thiyagarajan B, Shivasankar A, Pujari VS. Ultrasound-guided costoclavicular vs. axillary brachial plexus block: A randomized clinical study. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):655-660. doi: 10.4103/joacp.JOACP_43_20. Epub 2021 Nov 2.
- Background: PubMed 19700445Christophe JL, Berthier F, Boillot A, Tatu L, Viennet A, Boichut N, Samain E. Assessment of topographic brachial plexus nerves variations at the axilla using ultrasonography. Br J Anaesth. 2009 Oct;103(4):606-12. doi: 10.1093/bja/aep207. Epub 2009 Aug 21.
- Background: PubMed 14880419SMALL GA. Brachial plexus block anesthesia in children. J Am Med Assoc. 1951 Dec 22;147(17):1648-51. doi: 10.1001/jama.1951.03670340038009. No abstract available.
- Background: PubMed 28157792Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566.
- this work is the first we have done in adults " brachial intermediate nerve block"Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Emmanuel GUNTZ study director
Anesthesiologist
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Local and Brachial Plexus; Pressure, run by Centre Hospitalier Universitaire Saint Pierre.
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 4 inclusion and 7 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Raoul Ngatcha (+32493869805, ngatchag@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of the position of the nerves around the axillary artery (time frame: through study completion, around 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06158243, which also lists 4 linked publications.
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 6 Dec 2023.