Axillary Plexus Block in a High Resolution MRI
1 other identifier
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 15, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFebruary 13, 2014
February 1, 2014
2.1 years
December 15, 2009
February 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical efficacy of the blocks used compared with MRI findings
One year
Study Arms (3)
Arm 1: catheter injection
ACTIVE COMPARATOR40 ml of LA through the catheter
Arm 2: transarterial injection
ACTIVE COMPARATOR30 ml deep and 10 ml superficial to the artery
Arm 3: catheter and transarterial injection
ACTIVE COMPARATOR20 + 10 ml transarterial block and 10 ml through the catheter
Interventions
Eligibility Criteria
You may qualify if:
- patients scheduled for hand surgery
- ASA 1 - 2
- Weight from 50 - 95 kg
- MR compatible, suitable
You may not qualify if:
- Neurologic deficit
- Reaction to LA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Diakonhjemmet Hospitallead
- Oslo University Hospitalcollaborator
Study Sites (1)
The Intervention Centre, Rikshospitalet, Oslo University Hospital
Oslo, 0027, Norway
Related Publications (1)
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.
PMID: 25051144DERIVED
Related Links
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section manager
Study Record Dates
First Submitted
December 15, 2009
First Posted
December 16, 2009
Study Start
January 1, 2009
Primary Completion
February 1, 2011
Study Completion
August 1, 2012
Last Updated
February 13, 2014
Record last verified: 2014-02