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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02305875
Other study ID # S-04115B
Secondary ID
Status Completed
Phase N/A
First received November 19, 2014
Last updated May 15, 2015
Start date October 2014
Est. completion date May 2015

Study information

Verified date May 2015
Source Diakonhjemmet Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial Summary

The investigators have made a favourable experience with the in 2006 published transarterial triple injection method [4]. This classic method combines the block effect of an axillary catheter injection (median nerve position) with a double transarterial injection at terminal nerve level in the axilla.

The investigators experience after a recent published MRI study [3], confirms that a proximal axillary local anesthetic injection via an axillary catheter, guided by nerve stimulator, is beneficial for the block effect. The MRI study was conducted using nerve stimulation and a transarterial technique. The proximal injection with an effect at cord level, combined with axillary injections at terminal nerve level, produce an effective block distal to the elbow.

The proximal injection has obviously an effect to the lateral cord and the musculocutaneous nerve (mcn) [3]. Recent studies have advocated that a double axillary injection method is sufficient for the axillary block [5, 6]. Their block techniques included a selective block of the mcn at terminal nerve level. The investigators MRI study [3] demonstrated a successful block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of 15 patients) in the triple injection group without a selective block of this nerve. In the 1- deposit (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15 patients (73%) had the mcn successful blocked.

The objective in this study (Article 4) is to examine the mean position of the mcn nerve and its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal directed axillary catheter in median nerve position is beneficial in order to provide a successful mcn blockade? Is a selective injection to the mcn at terminal nerve level superfluous when a catheter is used?


Description:

45 patients were examined with MRI in a previous study [3] and now they underwent an additionally examination with a special focus on the anatomy and course of the mcn nerve. A line was drawn from the most cranial part of the humeral head perpendicular towards the brachial plexus. The distance from this line to the point where the mcn nerve entered the coracobrachial muscle was measured. This entering point was defined as the point where the mcn nerve left the axillary sheat. The visulaity of the mcn was scored as 0 = not visible, 1 = partly visible and 2 = clear visible.

The evaluation was a consensus assessment where all authors evaluated the T2-weighted, fat suppressed MRI images at the same time. If the mcn nerve could not be identified, the patients were excluded.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date May 2015
Est. primary completion date April 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients scheduled for hand surgery

- ASA 1 - 2

- Weight from 50 - 95 kg

- MR compatible, suitable

Exclusion Criteria:

- Neurologic deficit

- Reaction to LA

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
MCN scoring
Mcn's distance from top of the humeral head. Mcn's distance to the catheters insertion point. Mcn's distance and position in relationship to the axillary artery.

Locations

Country Name City State
Norway The Intervention Centre, Rikshospitalet, Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Position of the musculocutaneous nerve in the axillary sheat. Mean distance in cm to the humeral head and the insertion point of the catheter in 54 patients. 6 months No
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