Axillary Plexus Block in a High Resolution MRI

NCT ID: NCT01033006

Last Updated: 2014-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Nerve Block Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Arm 1: catheter injection

40 ml of LA through the catheter

Group Type ACTIVE_COMPARATOR

Active Comparator: Arm 1: catheter injection

Intervention Type PROCEDURE

Arm 2: transarterial injection

30 ml deep and 10 ml superficial to the artery

Group Type ACTIVE_COMPARATOR

Active Comparator: Arm 2: transarterial injection

Intervention Type PROCEDURE

Arm 3: catheter and transarterial injection

20 + 10 ml transarterial block and 10 ml through the catheter

Group Type ACTIVE_COMPARATOR

Active Comparator: Arm 3: catheter and transarterial injection

Intervention Type PROCEDURE

Interventions

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Active Comparator: Arm 1: catheter injection

Intervention Type PROCEDURE

Active Comparator: Arm 2: transarterial injection

Intervention Type PROCEDURE

Active Comparator: Arm 3: catheter and transarterial injection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Trygve Kjelstrup, MD

Section manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Trygve TK Kjelstrup, MD

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet Sykehus, University of Oslo

Øivind ØK Klaastad, PhD, MD

Role: STUDY_DIRECTOR

Rikshospitalet, Dep. of Anesthesiology, Oslo University Hospital

Locations

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The Intervention Centre, Rikshospitalet, Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Kjelstrup T, Hol PK, Courivaud F, Smith HJ, Rokkum M, Klaastad O. MRI of axillary brachial plexus blocks: a randomised controlled study. Eur J Anaesthesiol. 2014 Nov;31(11):611-9. doi: 10.1097/EJA.0000000000000122.

Reference Type DERIVED
PMID: 25051144 (View on PubMed)

Related Links

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http://ivs.no

The Intervention Centre

Other Identifiers

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S-04115

Identifier Type: -

Identifier Source: org_study_id

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