Axillary Plexus Block in a High Resolution MRI

Magnetic Resonance Imaging Clinical Trial

Official title:

Axillary Plexus Block in a High Resolution MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033006
• Other study ID #: S-04115
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2009
• Last updated: February 12, 2014
• Start date: January 2009
• Est. completion date: August 2012

Study information

• Verified date: February 2014
• 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

Background and aims:

Magnetic resonance imaging (MRI) has proved beneficial for presenting anatomy for regional anaesthesia and to demonstrate spread of local anaesthetic.

A new axillary plexus block with a triple injection (1), combining a short axillary catheter method with a transarterial axillary block, is now being evaluated with a 3 Tesla MRI. In this study, the investigators are investigating MR visualisation of three different block techniques and compare the clinical efficacy of the techniques, with the MR findings.

Patients & Methods:

After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult patients, scheduled for hand surgery, were included in a randomised, blinded prospective study.

Description:

After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult patients, scheduled for hand surgery, were included in a randomised, blinded prospective study.

In all patients a short axillary plexus catheter is positioned close to the median nerve using nerve stimulator.

Technique 1 = 40 ml in catheter Technique 2 = 30 ml behind and 10 ml in front of the brachial artery (BA) Technique 3 = 20 ml behind, 10ml in front of the BA and 10 ml in catheter

Clinical High Field MRI (3T) scanner has simplified the recognition of brachial plexus nerves in the axilla. After injection of local anaesthetic (LA), the identification of the nerve structures is nevertheless difficult. When all nerves are surrounded of LA in the axilla (MRI), it seems to be associated with a clinical complete brachial plexus block

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Magnetic Resonance Imaging
• Nerve Block

Intervention

Procedure:
• Active Comparator: Arm 1: catheter injection

• Active Comparator: Arm 2: transarterial injection

• Active Comparator: Arm 3: catheter and transarterial injection

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical efficacy of the blocks used compared with MRI findings		One year	No

External Links

•   The Intervention Centre
•   Trygve Kjelstrup, MD