- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03211949
Ultrasound Guided Topographic Mapping of Medial Antebrachial Cutaneous Nerve
Topographic Assessment of the Medial Antebrachial Cutaneous Nerve Variations at the Axilla and Above the Cubital Fossa Using Ultrasonography
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antwerp, Belgium, 2650
- University Hospital Antwerp
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all patients scheduled for lower arm/hand surgery
Exclusion Criteria:
- patient refusal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: axillary block with infiltration MCAN
With the performance of the axillary blok, 2 ml of scandicaine will be placed around the medial cutaneous ante brachial nerve (MACN)
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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
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
anatomical mapping of the MACN relative to the basilic vein, radial nerve and ulnar nerve
Time Frame: up to 30 minutes
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an ultrasound image will be stored with the structures marked
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up to 30 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: margaretha breebaart, Univeristy Hospital Antwerp
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/41/427
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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