- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06158243
Description of the Brachial Plexus Block at the Humeral Head in Children: a Sono-anatomical Study
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Raoul Ngatcha
- Phone Number: +32493869805
- Email: ngatchag@yahoo.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Study Director: Emmanuel GUNTZ, Anesthesiologist
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Anesthesia, Local
-
University Health Network, TorontoActive, not recruiting
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMRecruiting
-
Assistance Publique - Hôpitaux de ParisINSERM UMR-942, Paris, France; M3DISIMRecruitingPrediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population (CME)Anesthesia, Local | AnesthesiaFrance
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | AnesthesiaGermany
-
Grünenthal GmbHTerminatedAnalgesia | Anesthesia, Local | AnesthesiaNetherlands
-
Charite University, Berlin, GermanyCompletedAnesthesia, Local | Anesthesia | Anesthesia; Adverse EffectGermany
-
Novocol Pharmaceutical of Canada, Inc.CompletedAnesthesia, Local | Dental Anesthesia | Anesthesia, ReversalUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedAnesthesia, Local | Local Anesthetic Systemic ToxicityItaly
-
Kfir SiagNot yet recruiting
-
University Health Network, TorontoCompleted
Clinical Trials on Sono-anatomical Study
-
Istanbul UniversityRecruitingUterine Vein Injury Left | Uterine Vein Injury RightTurkey
-
Yonsei UniversityWithdrawnCardiac SurgeryKorea, Republic of
-
Yonsei UniversityUnknownPatients Undergoing SurgeryKorea, Republic of
-
SpirecutArcher ResearchCompletedCarpal Tunnel Syndrome | Trigger Finger | Trigger ThumbBelgium
-
Mansoura UniversityUnknownInternal Jugular Vein Cannulation
-
Centre Hospitalier Universitaire de NiceCompletedDental Caries | Enamel LesionsFrance
-
Erzurum Regional Training & Research HospitalNot yet recruitingDry Needling Lumbar Paraspinal Muscles
-
Tri-Service General HospitalEusol Biotech Co., Ltd.CompletedCarpal Tunnel SyndromeTaiwan
-
University Hospital Inselspital, BerneCompletedChronic Pelvic Pain SyndromeSwitzerland
-
Shanghai Chest HospitalXuzhou Central Hospital; Shandong University of Traditional Chinese Medicine; Changshu Hospital of Traditional Chinese Medicine and other collaboratorsNot yet recruitingAtrial Fibrillation (AF)China