Brachial Plexus BlockNCT02305875
The Musculocutaneous Nerve in a High Resolution MRI
A study testing MCN scoring in people with Brachial Plexus Block, run by Diakonhjemmet Hospital at 1 site in Norway.
Trial summary
The investigators have made a favourable experience with the in 2006 published transarterial triple injection method [4]. This classic method combines the block effect of an axillary catheter injection (median nerve position) with a double transarterial injection at terminal nerve level in the axilla. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brachial Plexus Block
- What is being tested?
- MCN scoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to May 2015
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- 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
Official title: The Musculocutaneous Nerve (Mcn) in a High Resolution MRI
The investigators have made a favourable experience with the in 2006 published transarterial triple injection method [4]. This classic method combines the block effect of an axillary catheter injection (median nerve position) with a double transarterial injection at terminal nerve level in the axilla.
The investigators experience after a recent published MRI study [3], confirms that a proximal axillary local anesthetic injection via an axillary catheter, guided by nerve stimulator, is beneficial for the block effect. The MRI study was conducted using nerve stimulation and a transarterial technique. The proximal injection with an effect at cord level, combined with axillary injections at terminal nerve level, produce an effective block distal to the elbow.
Read more
The proximal injection has obviously an effect to the lateral cord and the musculocutaneous nerve (mcn) [3]. Recent studies have advocated that a double axillary injection method is sufficient for the axillary block [5, 6]. Their block techniques included a selective block of the mcn at terminal nerve level. The investigators MRI study [3] demonstrated a successful block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of 15 patients) in the triple injection group without a selective block of this nerve. In the 1- deposit (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15 patients (73%) had the mcn successful blocked.
The objective in this study (Article 4) is to examine the mean position of the mcn nerve and its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal directed axillary catheter in median nerve position is beneficial in order to provide a successful mcn blockade? Is a selective injection to the mcn at terminal nerve level superfluous when a catheter is used?
Read the detailed description
45 patients were examined with MRI in a previous study [3] and now they underwent an additionally examination with a special focus on the anatomy and course of the mcn nerve. A line was drawn from the most cranial part of the humeral head perpendicular towards the brachial plexus. The distance from this line to the point where the mcn nerve entered the coracobrachial muscle was measured. This entering point was defined as the point where the mcn nerve left the axillary sheat. The visulaity of the mcn was scored as 0 = not visible, 1 = partly visible and 2 = clear visible.
The evaluation was a consensus assessment where all authors evaluated the T2-weighted, fat suppressed MRI images at the same time. If the mcn nerve could not be identified, the patients were excluded.
- Conditions
- Brachial Plexus Block
- Being tested
- MCN scoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCN scoringOther
Mcn's distance from top of the humeral head. Mcn's distance to the catheters insertion point. Mcn's distance and position in relationship to the axillary artery.
| Study group | Role | What they receive |
|---|---|---|
| MCN scoring | Experimental | Scoring of the mcn nerve's position in the axillary sheat using MRI Receives: Other: MCN scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Position of the musculocutaneous nerve in the axillary sheat. Mean distance in cm to the humeral head and the insertion point of the catheter in 54 patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trygve Kjelstrup, MD, Diakonhjemmet Hospital
- Investigators
- Per Kr Hol, PhD, Study director, University of Oslo, The Intervention Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305875
- Sponsor's protocol ID
- S-04115B
- Status last verified
- May 2015
- First submitted
- 19 Nov 2014
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Musculocutaneous Nerve (Mcn) in a High Resolution MRI
- ClinicalTrials.gov ID
- NCT02305875
- Acronym / sponsor ID
- S-04115B
- Conditions
- Brachial Plexus Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Dec 2014 (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.
The investigators have made a favourable experience with the in 2006 published transarterial triple injection method [4]. This classic method combines the block effect of an axillary catheter injection (median nerve position) with a double transarterial injection at terminal nerve level in the axilla.
The investigators experience after a recent published MRI study [3], confirms that a proximal axillary local anesthetic injection via an axillary catheter, guided by nerve stimulator, is beneficial for the block effect. The MRI study was conducted using nerve stimulation and a transarterial technique. The proximal injection with an effect at cord level, combined with axillary injections at terminal nerve level, produce an effective block distal to the elbow.
The proximal injection has obviously an effect to the lateral cord and the musculocutaneous nerve (mcn) [3]. Recent studies have advocated that a double axillary injection method is sufficient for the axillary block [5, 6]. Their block techniques included a selective block of the mcn at terminal nerve level. The investigators MRI study [3] demonstrated a successful block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of 15 patients) in the triple injection group without a selective block of this nerve. In the 1- deposit (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15 patients (73%) had the mcn successful blocked.
The objective in this study (Article 4) is to examine the mean position of the mcn nerve and its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal directed axillary catheter in median nerve position is beneficial in order to provide a successful mcn blockade? Is a selective injection to the mcn at terminal nerve level superfluous when a catheter is used?
Detailed description
45 patients were examined with MRI in a previous study [3] and now they underwent an additionally examination with a special focus on the anatomy and course of the mcn nerve. A line was drawn from the most cranial part of the humeral head perpendicular towards the brachial plexus. The distance from this line to the point where the mcn nerve entered the coracobrachial muscle was measured. This entering point was defined as the point where the mcn nerve left the axillary sheat. The visulaity of the mcn was scored as 0 = not visible, 1 = partly visible and 2 = clear visible.
The evaluation was a consensus assessment where all authors evaluated the T2-weighted, fat suppressed MRI images at the same time. If the mcn nerve could not be identified, the patients were excluded.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCN scoring | Experimental | Other: MCN scoringScoring of the mcn nerve's position in the axillary sheat using MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| MCN scoringMcn's distance from top of the humeral head. Mcn's distance to the catheters insertion point. Mcn's distance and position in relationship to the axillary artery. | Other | MCN scoring |
Primary outcome
Position of the musculocutaneous nerve in the axillary sheat. Mean distance in cm to the humeral head and the insertion point of the catheter in 54 patients.
Time frame: 6 months
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 18 May 2015.
Related trials for Brachial Plexus Block
Recruiting
Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: Selective Trunk Block vs Supraclavicular Brachial Plexus Block
Musculoskeletal Diseases or Conditions
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Perfusion Index in Monitoring Recovery From Brachial Plexus Block After Forearm Surgery
Forearm Surgeries, Brachial Plexus Blockade
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
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.
Per Kr Hol, PhD study director
University of Oslo, The Intervention Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCN scoring in people with Brachial Plexus Block, 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 18 May 2015. 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.
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?
Position of the musculocutaneous nerve in the axillary sheat. Mean distance in cm to the humeral head and the insertion point of the catheter in 54 patients. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2015.