The Axillary Region in a High Resolution MRI

NCT01442857 | Completed Phase 2

• 1 other identifier: S-04115A
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MRI Scanner Configuration

Keywords

Magnetic Resonance Imaging; Nerve Net; Brachial Plexus; Nerve block

Outcome Measures

Primary Outcomes (1)

• Pattern of local anaesthetic spread in axillary plexus block patients compared to MR images from volunteers without local anaesthesia injected.

  The optimized configuration of the 3.0 Tesla MRI scanner demonstrated detailed images from the volunteers and the patients. The image difference between the two groups was visualized and described. The investigators examined 9 volunteers and 9 patients. The volunteers were tested with different protocols in the 3.0 Tesla MRI providing anatomic pictures. The patients had two different brachial plexus blocks. Subsequently they were scanned with MRI and finally tested clinically for block efficacy before operation.

  3 years

Study Arms (1)

Block technique

EXPERIMENTAL

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

Radiation: MRI

Interventions

MRI RADIATION

High resolution MRI of the brachial plexus

Block technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Nerulogic disease or sequela

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• Oslo University Hospital: collaborator

Study Sites (1)

The Intervention Centre, Rikshospitalet, Oslo University Hospital

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 22571443 DERIVED

Related Links

• Link to The Intervention Centre, Oslo University Hospital

Study Officials

• Øivind ØK Klaastad, PhD, MD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section manager

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 29, 2011
• Study Start: June 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

NO (1)