Nerve BlockNCT03211949
Ultrasound Guided Topographic Mapping of Medial Antebrachial Cutaneous Nerve
A study testing axillary block and Scandicaine in people with Nerve Block and Surgery, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Blocking the medial antebrachial cutaneous nerve (MACN) during an axillary block often a subcutaneous wheal of local anesthetics is made what is described as painful. With the improvement of the resolution of the ultrasound machines smaller structures and nerves can be visable. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nerve Block, Surgery, Anesthesia
- What is being tested?
- axillary block and Scandicaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to 30 Jan 2020
- 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
- all patients scheduled for lower arm/hand surgery
Who cannot join
- patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topographic Assessment of the Medial Antebrachial Cutaneous Nerve Variations at the Axilla and Above the Cubital Fossa Using Ultrasonography
Blocking the medial antebrachial cutaneous nerve (MACN) during an axillary block often a subcutaneous wheal of local anesthetics is made what is described as painful. With the improvement of the resolution of the ultrasound machines smaller structures and nerves can be visable. In this study topographic assessment will made of the anatomical variation of the medial antebrachial cutaneous nerve (MACN) by ultrasound in the axilla and 5 cm above the cubital fossa of the arm.
Read the detailed description
The ethics committee will approved the study and informed consent is obtained. Patients with contraindications for regional anaesthesia will be excluded from the study. 150 patients will be included The arm is placed above and beside the head for scanning (abduction 90 degrees at the shoulder and 90 degrees flexion at the elbow with external rotation) Ultrasound is performed with a 12-18 MHz (Mega-Herz) linear probe (BK medical). The frequency is set to 18 MHz and the depth to 3 cm and adjusted to 1 cm below the brachial artery .
The terminal nerves of the brachial plexus (median, ulnar,radial an d musculocutaneous) are identified at the axillary fossa in a routine fashion described by Ranganath (see references).
After identifying the MACN at the axilla and 5 cm above the cubital fossa, the images at these two sites will be stored after digital marking of the MACN, the medial and ulnar nerve and the and radial nerve on the frozen ultrasound image. Its position relative to the venous structure and the artery at the axilla will be registered in the axilla at the lower border of the conjoint tendon of the teres major and the latissimus dorsi muscle.
After scanning the skin will be prepared with an aseptic solution and an axillary block will be performed with a 55 mm sonoplex 22 G short bevel ultrasound needle (Pajunk). With a partly in plane (ulnar, radial and MACN) and partly out of plane (median \& musculocutaneous nerve) technique . Mepivacaine 1.5 % will be injected around each nerve in the following order: Ulnar nerve, MACN, radial nerve, median nerve and musculocutaneous nerve. The time at which the MACN is blocked will be noted. For each nerve 5 ml of local anaesthetic solution will be injected except for the MACN nerve where 3 ml will be used because of its smaller caliber.
Nerve stimulation will be used with a current of 0,2 mA (milli Amps). Following completion of the block the dermatome supplied by the MACN will be tested by loss of cold sensation. After 20 minutes the dermatomes and motor function of all nerves are tested by elbow flexion and extension, primarily thumb opposition and abduction of the index finger. Sensory block is tested at the fifth finger (ulnar nerve, the hand palm at the thumb (medial nerve)and the dorsum of the hand ( radial nerve), the lateral (musculocutaneous nerve) and medial skin ( MACN) of the forearm.
Skin will be prepared with an aseptic solution and an axillary block will be performed with deposition of local anesthetic around the MACN.
Data processing. The locations of the different nerves will be displayed in a pie chart with the axillary artery in the centre, as well as the relative position to the basilic vein. Statistics will only be descriptive .
- Conditions
- Nerve Block, Surgery, Anesthesia, Brachial Plexus Block
- Being tested
- axillary block, Scandicaine
- Keywords
- axillary nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axillary blockProcedure or surgery
2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block
ScandicaineDrug
Also called mepivacaine
2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block
| Study group | Role | What they receive |
|---|---|---|
| axillary block with infiltration MCAN | Experimental | With the performance of the axillary blok, 2 ml of scandicaine will be placed around the medial cutaneous ante brachial nerve (MACN) Receives: Procedure: axillary block; Drug: Scandicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
anatomical mapping of the MACN relative to the basilic vein, radial nerve and ulnar nerve
an ultrasound image will be stored with the structures marked
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startSep 2014
- Primary completionDec 2019
- Study completion30 Jan 2020
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 Nerve BlockStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr M. B. Breebaart, University Hospital, Antwerp
- Investigators
- margaretha breebaart, Principal investigator, Univeristy Hospital Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211949
- Sponsor's protocol ID
- 14/41/427
- Status last verified
- Aug 2022
- First submitted
- 30 Oct 2014
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Ranganath A, Srinivasan KK, Iohom G. Ultrasound guided axillary brachial plexus block. Med Ultrason. 2014 Sep;16(3):246-51. doi: 10.11152/mu.2013.2066.163.2kks.
PubMed 25110766
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topographic Assessment of the Medial Antebrachial Cutaneous Nerve Variations at the Axilla and Above the Cubital Fossa Using Ultrasonography
- ClinicalTrials.gov ID
- NCT03211949
- Acronym / sponsor ID
- 14/41/427
- Conditions
- Nerve Block, Surgery, Anesthesia, Brachial Plexus Block
- Keywords
- axillary nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- 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.
Blocking the medial antebrachial cutaneous nerve (MACN) during an axillary block often a subcutaneous wheal of local anesthetics is made what is described as painful. With the improvement of the resolution of the ultrasound machines smaller structures and nerves can be visable. In this study topographic assessment will made of the anatomical variation of the medial antebrachial cutaneous nerve (MACN) by ultrasound in the axilla and 5 cm above the cubital fossa of the arm.
Detailed description
The ethics committee will approved the study and informed consent is obtained. Patients with contraindications for regional anaesthesia will be excluded from the study. 150 patients will be included The arm is placed above and beside the head for scanning (abduction 90 degrees at the shoulder and 90 degrees flexion at the elbow with external rotation) Ultrasound is performed with a 12-18 MHz (Mega-Herz) linear probe (BK medical). The frequency is set to 18 MHz and the depth to 3 cm and adjusted to 1 cm below the brachial artery .
The terminal nerves of the brachial plexus (median, ulnar,radial an d musculocutaneous) are identified at the axillary fossa in a routine fashion described by Ranganath (see references).
After identifying the MACN at the axilla and 5 cm above the cubital fossa, the images at these two sites will be stored after digital marking of the MACN, the medial and ulnar nerve and the and radial nerve on the frozen ultrasound image. Its position relative to the venous structure and the artery at the axilla will be registered in the axilla at the lower border of the conjoint tendon of the teres major and the latissimus dorsi muscle.
After scanning the skin will be prepared with an aseptic solution and an axillary block will be performed with a 55 mm sonoplex 22 G short bevel ultrasound needle (Pajunk). With a partly in plane (ulnar, radial and MACN) and partly out of plane (median \& musculocutaneous nerve) technique . Mepivacaine 1.5 % will be injected around each nerve in the following order: Ulnar nerve, MACN, radial nerve, median nerve and musculocutaneous nerve. The time at which the MACN is blocked will be noted. For each nerve 5 ml of local anaesthetic solution will be injected except for the MACN nerve where 3 ml will be used because of its smaller caliber.
Nerve stimulation will be used with a current of 0,2 mA (milli Amps). Following completion of the block the dermatome supplied by the MACN will be tested by loss of cold sensation. After 20 minutes the dermatomes and motor function of all nerves are tested by elbow flexion and extension, primarily thumb opposition and abduction of the index finger. Sensory block is tested at the fifth finger (ulnar nerve, the hand palm at the thumb (medial nerve)and the dorsum of the hand ( radial nerve), the lateral (musculocutaneous nerve) and medial skin ( MACN) of the forearm.
Skin will be prepared with an aseptic solution and an axillary block will be performed with deposition of local anesthetic around the MACN.
Data processing. The locations of the different nerves will be displayed in a pie chart with the axillary artery in the centre, as well as the relative position to the basilic vein. Statistics will only be descriptive .
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| axillary block with infiltration MCAN | Experimental | Procedure: axillary block, Drug: ScandicaineWith the performance of the axillary blok, 2 ml of scandicaine will be placed around the medial cutaneous ante brachial nerve (MACN) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients scheduled for lower arm/hand surgery
Key exclusion criteria (1 listed)
- patient refusal
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 |
|---|---|---|
| axillary block2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block | Procedure or surgery | axillary block with infiltration MCAN |
| ScandicaineAlso: mepivacaine2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block | Drug | axillary block with infiltration MCAN |
Primary outcome
anatomical mapping of the MACN relative to the basilic vein, radial nerve and ulnar nerve
Time frame: up to 30 minutes
an ultrasound image will be stored with the structures marked
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 5 Aug 2022.
- Background: PubMed 25110766Ranganath A, Srinivasan KK, Iohom G. Ultrasound guided axillary brachial plexus block. Med Ultrason. 2014 Sep;16(3):246-51. doi: 10.11152/mu.2013.2066.163.2kks.
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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.
margaretha breebaart principal investigator
Univeristy Hospital Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing axillary block and Scandicaine in people with Nerve Block and Surgery, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 inclusion and 1 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 5 Aug 2022. 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 Belgium. 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?
anatomical mapping of the MACN relative to the basilic vein, radial nerve and ulnar nerve (time frame: up to 30 minutes). 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 NCT03211949, 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 5 Aug 2022.