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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01033006
Other study ID # S-04115
Secondary ID
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


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
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