Axillary Plexus Block in a High Resolution MRI

February 12, 2014 updated by: Trygve Kjelstrup, MD, Diakonhjemmet Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • The Intervention Centre, Rikshospitalet, Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical efficacy of the blocks used compared with MRI findings
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonhjemmet Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (Estimate)

December 16, 2009

Study Record Updates

Last Update Posted (Estimate)

February 13, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-04115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Magnetic Resonance Imaging

Clinical Trials on Active Comparator: Arm 1: catheter injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe