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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06158243
Other study ID # B062023230501
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2023
Est. completion date April 2024

Study information

Verified date November 2023
Source Centre Hospitalier Universitaire Saint Pierre
Contact Raoul Ngatcha
Phone +32493869805
Email ngatchag@yahoo.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 artery, and the description of bone and muscle structures.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 10 Years
Eligibility Inclusion Criteria: - patient ASA 1-2 - aged 0 to 10 years - scheduled surgery - parental consent obtained Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sono-anatomical Study
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

References & Publications (4)

Christophe 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. — View Citation

Li 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. — View Citation

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. — View Citation

SMALL 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 through study completion, around 5 months
Secondary 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 through study completion, around 5 months
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