Description of the Brachial Plexus Block at the Humeral Head in Children: a Sono-anatomical Study

November 27, 2023 updated by: Raoul Ngatcha, Centre Hospitalier Universitaire Saint Pierre
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.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
0-2
children aged 0 to 2 years
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.
2-4
children aged 2 to 4 years
4-6
children aged 4 to 6 years
6-8
children aged 6 to 8 years
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.
8-10
children aged 8 to 10 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, around 5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
distance between anatomical structures
Time Frame: through study completion, around 5 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Emmanuel GUNTZ, Anesthesiologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Estimated)

December 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B062023230501

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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