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Axillary Plexus Block in a High Resolution MRI

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01033006
First Posted: December 16, 2009
Last Update Posted: February 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Trygve Kjelstrup, MD, Diakonhjemmet Hospital
December 15, 2009
December 16, 2009
February 13, 2014
January 2009
February 2011   (Final data collection date for primary outcome measure)
Clinical efficacy of the blocks used compared with MRI findings [ Time Frame: One year ]
Same as current
Complete list of historical versions of study NCT01033006 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Axillary Plexus Block in a High Resolution MRI
Axillary Plexus Block in a High Resolution MRI

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.

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

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Nerve Block
  • Magnetic Resonance Imaging
  • Procedure: Active Comparator: Arm 1: catheter injection
  • Procedure: Active Comparator: Arm 2: transarterial injection
  • Procedure: Active Comparator: Arm 3: catheter and transarterial injection
  • Active Comparator: Arm 1: catheter injection
    40 ml of LA through the catheter
    Intervention: Procedure: Active Comparator: Arm 1: catheter injection
  • Active Comparator: Arm 2: transarterial injection
    30 ml deep and 10 ml superficial to the artery
    Intervention: Procedure: Active Comparator: Arm 2: transarterial injection
  • Active Comparator: Arm 3: catheter and transarterial injection
    20 + 10 ml transarterial block and 10 ml through the catheter
    Intervention: Procedure: Active Comparator: Arm 3: catheter and transarterial injection
Kjelstrup T, Hol PK, Courivaud F, Smith HJ, Røkkum M, Klaastad Ø. MRI of axillary brachial plexus blocks: a randomised controlled study. Eur J Anaesthesiol. 2014 Nov;31(11):611-9. doi: 10.1097/EJA.0000000000000122.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 2012
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01033006
S-04115
Yes
Not Provided
Not Provided
Trygve Kjelstrup, MD, Diakonhjemmet Hospital
Diakonhjemmet Hospital
Oslo University Hospital
Principal Investigator: Trygve TK Kjelstrup, MD Diakonhjemmet Sykehus, University of Oslo
Study Director: Øivind ØK Klaastad, PhD, MD Rikshospitalet, Dep. of Anesthesiology, Oslo University Hospital
Diakonhjemmet Hospital
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP