Nerve BlockPhase 2NCT01033006
Axillary Plexus Block in a High Resolution MRI
A Phase 2 study testing Active Comparator: Arm 1: catheter injection, Active Comparator: Arm 2: transarterial injection and Active Comparator: Arm 3: catheter and transarterial injection in people with Nerve Block and Magnetic Resonance Imaging, run by Diakonhjemmet Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nerve Block, Magnetic Resonance Imaging
- What is being tested?
- Active Comparator: Arm 1: catheter injection, Active Comparator: Arm 2: transarterial injection and Active Comparator: Arm 3: catheter and transarterial injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2009to Aug 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for hand surgery
- ASA 1 - 2
- Weight from 50 - 95 kg
- MR compatible, suitable
Who cannot join
- Neurologic deficit
- Reaction to LA
Trial locations and contacts
1 site in 1 country.
Norway1 site
The Intervention Centre, Rikshospitalet, Oslo University Hospital
Oslo, 0027
About this study
Background and aims:
Magnetic resonance imaging (MRI) has proved beneficial for presenting anatomy for regional anaesthesia and to demonstrate spread of local anaesthetic.
Read more
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.
Read the 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
- Conditions
- Nerve Block, Magnetic Resonance Imaging
- Being tested
- Active Comparator: Arm 1: catheter injection, Active Comparator: Arm 2: transarterial injection, Active Comparator: Arm 3: catheter and transarterial injection
- Keywords
- Peripheral Nerves, Axillary Block, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Arm 1: catheter injectionProcedure or surgery
Active Comparator: Arm 2: transarterial injectionProcedure or surgery
Active Comparator: Arm 3: catheter and transarterial injectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: catheter injection | Active comparator | 40 ml of LA through the catheter Receives: Procedure: Active Comparator: Arm 1: catheter injection |
| Arm 2: transarterial injection | Active comparator | 30 ml deep and 10 ml superficial to the artery Receives: Procedure: Active Comparator: Arm 2: transarterial injection |
| Arm 3: catheter and transarterial injection | Active comparator | 20 + 10 ml transarterial block and 10 ml through the catheter Receives: Procedure: Active Comparator: Arm 3: catheter and transarterial injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of the blocks used compared with MRI findings
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Trygve Kjelstrup, MD, Diakonhjemmet Hospital
- Investigators
- Trygve TK Kjelstrup, MD, Principal investigator, Diakonhjemmet Sykehus, University of OsloØivind ØK Klaastad, PhD, MD, Study director, Rikshospitalet, Dep. of Anesthesiology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033006
- Sponsor's protocol ID
- S-04115
- Status last verified
- Feb 2014
- First submitted
- 15 Dec 2009
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25051144
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Plexus Block in a High Resolution MRI
- ClinicalTrials.gov ID
- NCT01033006
- Acronym / sponsor ID
- S-04115
- Conditions
- Nerve Block, Magnetic Resonance Imaging
- Keywords
- Peripheral Nerves, Axillary Block, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: catheter injection | Active comparator | Procedure: Active Comparator: Arm 1: catheter injection40 ml of LA through the catheter |
| Arm 2: transarterial injection | Active comparator | Procedure: Active Comparator: Arm 2: transarterial injection30 ml deep and 10 ml superficial to the artery |
| Arm 3: catheter and transarterial injection | Active comparator | Procedure: Active Comparator: Arm 3: catheter and transarterial injection20 + 10 ml transarterial block and 10 ml through the catheter |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients scheduled for hand surgery
- ASA 1 - 2
- Weight from 50 - 95 kg
- MR compatible, suitable
Key exclusion criteria (2 listed)
- Neurologic deficit
- Reaction to LA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: Arm 1: catheter injection | Procedure or surgery | Arm 1: catheter injection |
| Active Comparator: Arm 2: transarterial injection | Procedure or surgery | Arm 2: transarterial injection |
| Active Comparator: Arm 3: catheter and transarterial injection | Procedure or surgery | Arm 3: catheter and transarterial injection |
Primary outcome
Clinical efficacy of the blocks used compared with MRI findings
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Derived from this study: PubMed 25051144Kjelstrup 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.
- The Intervention CentreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trygve TK Kjelstrup, MD principal investigator
Diakonhjemmet Sykehus, University of Oslo
Øivind ØK Klaastad, PhD, MD study director
Rikshospitalet, Dep. of Anesthesiology, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Comparator: Arm 1: catheter injection, Active Comparator: Arm 2: transarterial injection and Active Comparator: Arm 3: catheter and transarterial injection in people with Nerve Block and Magnetic Resonance Imaging, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of the blocks used compared with MRI findings (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2014.