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Axillary Plexus Block in a High Resolution MRI

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Trygve Kjelstrup, MD, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01033006
First received: December 15, 2009
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
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
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Axillary Plexus Block in a High Resolution MRI

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
U.S. FDA Resources

Further study details as provided by Diakonhjemmet Hospital:

Primary Outcome Measures:
  • Clinical efficacy of the blocks used compared with MRI findings [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: January 2009
Estimated Study Completion Date: May 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: catheter injection
40 ml of LA through the catheter
 Procedure: Active Comparator: Arm 1: catheter injection
Active Comparator: Arm 2: transarterial injection
30 ml deep and 10 ml superficial to the artery
 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
 Procedure: Active Comparator: Arm 3: catheter and transarterial injection

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033006

Locations
Norway
The Intervention Centre, Rikshospitalet, Oslo University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Diakonhjemmet Hospital
Oslo University Hospital
Investigators
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
  More Information

Additional Information:
The Intervention Centre  This link exits the ClinicalTrials.gov site
Trygve Kjelstrup, MD  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Trygve Kjelstrup, MD, Section manager, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01033006     History of Changes
Other Study ID Numbers: S-04115
Study First Received: December 15, 2009
Last Updated: February 4, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Diakonhjemmet Hospital:
Peripheral Nerves
Axillary Block
MRI

ClinicalTrials.gov processed this record on May 23, 2013