Sonographic Detection of Musculocutaneous NerveNCT02168699
Ultrasonographic Detection of Musculocutaneous Nerve in Children
A study testing Ultrasound examination of the axilla in people with Sonographic Detection of Musculocutaneous Nerve, run by Attikon Hospital at 1 site in Greece.
Trial summary
Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while there is limited information regarding… Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sonographic Detection of Musculocutaneous Nerve
- What is being tested?
- Ultrasound examination of the axilla
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGreece
- Study dates
- Dec 2010to Mar 2012
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children 0-12 years old
- parental written informed consent
Who cannot join
- parental refusal
- children refusal
- previous operations to the axilla
- anatomical malformations of the axilla
- spasticity
- morbid obesity.
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, 12462
About this study
Official title: Ultrasound Imaging of Musculocutaneous Nerve in Infants, Preschoolers and Children
Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while there is limited information regarding ultrasound imaging of the musculocutaneous nerve in children.
The aim of this prospective imaging study is to investigate whether musculocutaneous nerve is visualized in childhood with the use of ultrasound imaging or not. A secondary aim of this study is to assess the percentage of its visualization according to the age.
Read more
Parental written informed consent is obtained from all participants. The children are divided into three groups according to their age: Group 1, with infants aged less than 12 months; Group 2, with toddlers and preschoolers; and Group 3, with school-aged children (6.5-12 years).
Children are placed in the supine position with the involved arm abducted at 90° and the elbow flexed at 90°. The linear probe of a portable ultrasound machine is placed at the axillary region, perpendicularly to the axillary artery. The musculocutaneous nerve is searched near the axillary artery (proximally) and its course is followed distally (into the coracobrachialis muscle). Its sonographic detection is recorded in these two sites, both proximally and distally.
- Being tested
- Ultrasound examination of the axilla
- Keywords
- children, infants, musculocutaneous nerve, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination of the axillaOther
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound examination | Other | Ultrasound examination of the axillary region in children Receives: Other: Ultrasound examination of the axilla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assession of the ultrasonographic visualization rate of musculocutaneous nerve in children
Measured: Data is assessed during sonographic examination of the axillary region
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startDec 2010
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sonographic Detection of Musculocutaneous NerveStudies 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
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paraskevi Matsota, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168699
- Sponsor's protocol ID
- ATTIK12112
- Status last verified
- Jun 2014
- First submitted
- 18 Jun 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of Musculocutaneous Nerve in Infants, Preschoolers and Children
- ClinicalTrials.gov ID
- NCT02168699
- Acronym / sponsor ID
- ATTIK12112
- Keywords
- children, infants, musculocutaneous nerve, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- First posted
- 20 Jun 2014 (estimated)
- 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.
Localizing the musculocutaneous nerve for neural blockade is crucial to achieve complete anesthesia of the forearm. However, in pediatric anesthesiology, the musculocutaneous nerve is unable to be blocked in up to 40-50% of cases when only neurostimulation is used, while there is limited information regarding ultrasound imaging of the musculocutaneous nerve in children.
The aim of this prospective imaging study is to investigate whether musculocutaneous nerve is visualized in childhood with the use of ultrasound imaging or not. A secondary aim of this study is to assess the percentage of its visualization according to the age.
Parental written informed consent is obtained from all participants. The children are divided into three groups according to their age: Group 1, with infants aged less than 12 months; Group 2, with toddlers and preschoolers; and Group 3, with school-aged children (6.5-12 years).
Children are placed in the supine position with the involved arm abducted at 90° and the elbow flexed at 90°. The linear probe of a portable ultrasound machine is placed at the axillary region, perpendicularly to the axillary artery. The musculocutaneous nerve is searched near the axillary artery (proximally) and its course is followed distally (into the coracobrachialis muscle). Its sonographic detection is recorded in these two sites, both proximally and distally.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound examination | Other | Other: Ultrasound examination of the axillaUltrasound examination of the axillary region in children |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children 0-12 years old
- parental written informed consent
Key exclusion criteria (6 listed)
- parental refusal
- children refusal
- previous operations to the axilla
- anatomical malformations of the axilla
- spasticity
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 examination of the axilla | Other | Ultrasound examination |
Primary outcome
Assession of the ultrasonographic visualization rate of musculocutaneous nerve in children
Time frame: Data is assessed during sonographic examination of the axillary region
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound examination of the axilla in people with Sonographic Detection of Musculocutaneous Nerve, run by Attikon Hospital at 1 site in Greece.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 20 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assession of the ultrasonographic visualization rate of musculocutaneous nerve in children (time frame: Data is assessed during sonographic examination of the axillary region). 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 20 Jun 2014.