Upper Limb SurgeryECHO_NCMBNCT02940847
Ultrasound-guided Versus Blind Technique in Medial Brachial Cutaneous Nerve and Intercostobrachial Nerve Blocks
A study testing medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique and medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique in people with Upper Limb Surgery, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Surgery
- What is being tested?
- medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique and medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2016to Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years
- Surgery of the distal upper limb : hand, forearm, lower third of the arm ,including the elbow
- Urgent or planned surgery
- Locoregional anesthesia : axillary brachial plexus block, completed by a medial brachial cutaneous nerve block and an intercostobrachial nerve block
- Local anesthetic used : mepivacaine 10mg/ml
- In the absence of patient objections
Who cannot join
- Pregnancy
- Adults under guardianship
- Locoregional anesthesia contraindications
- Local anesthetic used : ropivacaine 0,75%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Ultrasound-guided Technique Compared to Blind Technique in Medial Brachial Cutaneous Nerve Block and Intercostobrachial Nerve Block, in the Axilla
The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow. The anesthesia of the posterior and the medial side of the arm requires a selective block of the medial brachial cutaneous nerve and the intercostobrachial nerve, for example to improve the tolerance of the inflatable tourniquet used by the surgeons. There are two techniques to achieve this block : the blind technique (without ultrasound) and the ultrasound-guided technique. At the moment, there are no studies which compare these two techniques. So, the purpose of this study is to determine the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercostobrachial nerve block, in the axilla.
Read the detailed description
For purposes of this single-blind monocentric study, 84 patients are randomized into two groups (42 patients for each), upon enrolment into the study.
In the first group, the blind technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : it consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.
In the second group, the ultrasound-guided technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.
The aim is to evaluate the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercosto-brachial nerve block, in the axilla
- Conditions
- Upper Limb Surgery
- Being tested
- medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique, medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique
- Keywords
- ultrasound-guided technique, blind technique, medial brachial cutaneous nerve block, intercostobrachial nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial brachial cutaneous nerve block and intercostobrachial nerve block with blind techniqueProcedure or surgery
It consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.
medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided techniqueProcedure or surgery
Ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.
| Study group | Role | What they receive |
|---|---|---|
| blind technique | Active comparator | Investigators will perform a medial brachial cutaneous nerve block and an intercostobrachial nerve block with either a blind technique or an ultrasound-guided technique to estimate the effectiveness of each technique. The blind technique consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction. Receives: Procedure: medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique |
| ultrasound-guided technique | Active comparator | Investigators will perform a medial brachial cutaneous nerve block and an intercostobrachial nerve block with either a blind technique or an ultrasound-guided technique to estimate the effectiveness of each technique. In the ultrasound-guided technique, ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion. Receives: Procedure: medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with complete anesthesia in the lower half of the medial cutaneous area of the arm, at time 20 minutes
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Measured: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
Number of participants with complete anesthesia in the upper half of the medial cutaneous area of the arm, at time 20 minutes
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Measured: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
Number of participants with complete anesthesia in the lower half of the posterior cutaneous area of the arm, at time 20 minutes
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Measured: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
Number of participants with complete anesthesia in the upper half of the posterior cutaneous area of the arm, at time 20 minutes
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Measured: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
Number of participants with complete anesthesia of the arm at time 20 minutes
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Measured: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
Secondary outcomes (6)
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia at times 5, 10, 15, 20 minutes (except primary outcome) in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve
Measured: at times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of patients with comfortable feeling, with unpleasant sensations and with pains during surgery, in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve (questionnaire completed by the anesthesist)
Measured: 3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
The total volume (mL) of local anesthetic used for the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Measured: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with good ultrasound view of theses nerves before and after the injection of the local anesthetic
Measured: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with : bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic
Measured: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before and after the injection of the local anesthetic.
Measured: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start13 Nov 2016
- Primary completion26 Jan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb SurgeryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé BOUAZIZ, Professor, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940847
- Sponsor's protocol ID
- 2016-A01296-45
- Acronym
- ECHO_NCMB
- Status last verified
- Jul 2017
- First submitted
- 16 Oct 2016
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Magazzeni P, Jochum D, Iohom G, Mekler G, Albuisson E, Bouaziz H. Ultrasound-Guided Selective Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves: A Randomized Clinical Trial. Reg Anesth Pain Med. 2018 Nov;43(8):832-837. doi: 10.1097/AAP.0000000000000823.
PubMed 29905631
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Ultrasound-guided Technique Compared to Blind Technique in Medial Brachial Cutaneous Nerve Block and Intercostobrachial Nerve Block, in the Axilla
- ClinicalTrials.gov ID
- NCT02940847
- Acronym / sponsor ID
- ECHO_NCMB / 2016-A01296-45
- Conditions
- Upper Limb Surgery
- Keywords
- ultrasound-guided technique, blind technique, medial brachial cutaneous nerve block, intercostobrachial nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Nov 2016 (actual)
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Oct 2016 (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.
The axillary brachial plexus block is a technique of locoregional anesthesia indicated in the distal upper limb surgery : hand, forearm, the lower third of the arm including the elbow. The anesthesia of the posterior and the medial side of the arm requires a selective block of the medial brachial cutaneous nerve and the intercostobrachial nerve, for example to improve the tolerance of the inflatable tourniquet used by the surgeons. There are two techniques to achieve this block : the blind technique (without ultrasound) and the ultrasound-guided technique. At the moment, there are no studies which compare these two techniques. So, the purpose of this study is to determine the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercostobrachial nerve block, in the axilla.
Detailed description
For purposes of this single-blind monocentric study, 84 patients are randomized into two groups (42 patients for each), upon enrolment into the study.
In the first group, the blind technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : it consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.
In the second group, the ultrasound-guided technique is used to perform the medial brachial cutaneous nerve block and the intercostobrachial nerve block : ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.
The aim is to evaluate the effectiveness of ultrasound-guided technique compared to blind technique in medial brachial cutaneous nerve block and intercosto-brachial nerve block, in the axilla
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blind technique | Active comparator | Procedure: medial brachial cutaneous nerve block and intercostobrachial nerve block with blind techniqueInvestigators will perform a medial brachial cutaneous nerve block and an intercostobrachial nerve block with either a blind technique or an ultrasound-guided technique to estimate the effectiveness of each technique. The blind technique consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction. |
| ultrasound-guided technique | Active comparator | Procedure: medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided techniqueInvestigators will perform a medial brachial cutaneous nerve block and an intercostobrachial nerve block with either a blind technique or an ultrasound-guided technique to estimate the effectiveness of each technique. In the ultrasound-guided technique, ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients ≥ 18 years
- Surgery of the distal upper limb : hand, forearm, lower third of the arm ,including the elbow
- Urgent or planned surgery
- Locoregional anesthesia : axillary brachial plexus block, completed by a medial brachial cutaneous nerve block and an intercostobrachial nerve block
- Local anesthetic used : mepivacaine 10mg/ml
Key exclusion criteria (4 listed)
- Pregnancy
- Adults under guardianship
- Locoregional anesthesia contraindications
- Local anesthetic used : ropivacaine 0,75%
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 |
|---|---|---|
| medial brachial cutaneous nerve block and intercostobrachial nerve block with blind techniqueIt consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction. | Procedure or surgery | blind technique |
| medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided techniqueUltrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion. | Procedure or surgery | ultrasound-guided technique |
Primary outcome
Number of participants with complete anesthesia in the lower half of the medial cutaneous area of the arm, at time 20 minutes
Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Number of participants with complete anesthesia in the upper half of the medial cutaneous area of the arm, at time 20 minutes
Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Number of participants with complete anesthesia in the lower half of the posterior cutaneous area of the arm, at time 20 minutes
Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Number of participants with complete anesthesia in the upper half of the posterior cutaneous area of the arm, at time 20 minutes
Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
Number of participants with complete anesthesia of the arm at time 20 minutes
Time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block
At time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block, a light touch sensitivity test is performed
6 secondary outcomes
Number of participants with complete anesthesia, with reduced sensitivity and with absence of anesthesia at times 5, 10, 15, 20 minutes (except primary outcome) in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve
Time frame: at times 5, 10, 15, 20 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of patients with comfortable feeling, with unpleasant sensations and with pains during surgery, in the areas of the medial brachial cutaneous nerve and the intercostobrachial nerve (questionnaire completed by the anesthesist)
Time frame: 3 hours after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
The total volume (mL) of local anesthetic used for the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with good ultrasound view of theses nerves before and after the injection of the local anesthetic
Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with : bad ultrasound view of theses nerves before the injection and good ultrasound view of theses nerves after the injection of the local anesthetic
Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
Number of participants (of the ultrasound-guided group) with bad ultrasound view of theses nerves before and after the injection of the local anesthetic.
Time frame: 5 minutes after the achievement of the medial brachial cutaneous nerve block and the intercostobrachial nerve block
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 28 Jul 2017.
- Derived from this study: PubMed 29905631Magazzeni P, Jochum D, Iohom G, Mekler G, Albuisson E, Bouaziz H. Ultrasound-Guided Selective Versus Conventional Block of the Medial Brachial Cutaneous and the Intercostobrachial Nerves: A Randomized Clinical Trial. Reg Anesth Pain Med. 2018 Nov;43(8):832-837. doi: 10.1097/AAP.0000000000000823.
- 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.
Hervé BOUAZIZ, Professor study director
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique and medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique in people with Upper Limb Surgery, run by Central Hospital, Nancy, France at 1 site in France.
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 6 inclusion and 4 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 28 Jul 2017. 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 France. 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?
Number of participants with complete anesthesia in the lower half of the medial cutaneous area of the arm, at time 20 minutes (time frame: at time 20 minutes after the achievement of medial brachial cutaneous nerve block and intercostobrachial nerve block). The study lists 5 primary outcomes in all. 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 NCT02940847, which also lists 1 linked publication.
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 28 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.