The Axillary Region in a High Resolution MRI

NCT ID: NCT01442857

Last Updated: 2014-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-12-31

Brief Summary

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The axillary region is regularly used for brachial plexus block. The technique may be guided by nerve stimulation, ultrasound or a combination of nerve stimulation and ultrasound. Magnetic resonance imaging (MRI) has been beneficial in presenting anatomy of interest for regional anesthesia and in demonstrating spread of local anesthetic (LA). An axillary MRI-study at our department supported the suggestion of multiple rather than a single injection technique. Using a 0.5 Tesla open MR scanner in that study, the investigators were not able to distinguish terminal nerves from equally sized vessels. Therefore the investigators could not definitely answer whether the LA reached the pertinent nerves. The investigators have recently performed an axillary block study with a 3.0 Tesla scanner. Now the terminal nerves were identified and for each patient the investigators could observe if the LA reached the nerves.

The aim of this study was to demonstrate the anatomy of the brachial plexus in the axillary region at different levels. The investigators present the best pictures of the nerves with and without LA injected. The images are demonstrated in the axial and coronal plane.

Detailed Description

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For upper limb surgery, the brachial plexus can be blocked at the interscalene, supraclavicular, infraclavicular and axillary level as an alternative to general anesthesia. The axillary block requires more deposits to achieve a complete block. MRI investigations are of interest to better understand the block specific distribution of LA. With the new MRI Achieva 3.0T X-series (Philips Electronics, Eindhoven the Netherlands), with resolutions beyond 100μm using 2k imaging, we expected new information also compared with the earlier axillary MRI publication from our department. In that former study we used a single deposit technique in an open 0.5 Tesla scanner. We could not in that study recognize the terminal nerves or determine if the LA reached the axillary plexus.

MRI publications of the brachial plexus mostly study the shoulder region and few are describing the axillary region. We did not find any article describing the axillary brachial plexus using a 3.0 Tesla high resolution MRI.

Ultrasound visualizes the plexus nerves in the axilla and demonstrates dynamically the spread of LA. This usually occurs in 2-dimensional images where the initially observed LA fades after some minutes. MRI provides more easy 3 - dimensional images also in oblique planes compared with ultrasound.

This study was done in order to demonstrate the relevant anatomy in the volunteers and the spread of LA in patients. We also present the used protocols and MRI - stacks after having optimized the configuration of the 3.0 MRI scanner.

Conditions

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MRI Scanner Configuration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Block technique

Active Comparator: Arm 1: catheter injection 40 ml of LA through the catheter

Active Comparator: Arm 2: catheter and transarterial injection 20 + 10 ml transarterial block and 10 ml through the catheter

Group Type EXPERIMENTAL

MRI

Intervention Type RADIATION

High resolution MRI of the brachial plexus

Interventions

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MRI

High resolution MRI of the brachial plexus

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* ASA 1 - 2.
* Anatomic volunteers or patients scheduled for hand surgery

Exclusion Criteria

* Nerulogic disease or sequela
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Trygve Kjelstrup, MD

Section manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Øivind ØK Klaastad, PhD, MD

Role: STUDY_DIRECTOR

Oslo University Hospital

Locations

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The Intervention Centre, Rikshospitalet, Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Kjelstrup T, Courivaud F, Klaastad O, Breivik H, Hol PK. High-resolution MRI demonstrates detailed anatomy of the axillary brachial plexus. A pilot study. Acta Anaesthesiol Scand. 2012 Aug;56(7):914-9. doi: 10.1111/j.1399-6576.2012.02703.x. Epub 2012 May 9.

Reference Type DERIVED
PMID: 22571443 (View on PubMed)

Related Links

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http://www.ivs.no

Link to The Intervention Centre, Oslo University Hospital

Other Identifiers

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S-04115A

Identifier Type: -

Identifier Source: org_study_id

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