Nerve InjuryNCT03881462
Deltoid Muscle Contribution to Shoulder Function
A study testing Axillary nerve block for artificial deltoid muscle palsy in people with Nerve Injury and Nerve Palsy, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
There is only one study in the literature about the quantitative effect of M. deltoideus on the movement of the shoulder. Here, the author described a 35-80% loss of abduction power after selective blockade of the N. axillaris. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Injury, Nerve Palsy
- What is being tested?
- Axillary nerve block for artificial deltoid muscle palsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2019to 30 Sep 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of anesthesiologists (ASA) classification I - II, both sexes
- ≥ 18 years old
- < 65 years old
- Written informed consent as documented by signature
Who cannot join
- Severe coagulopathy or intake of anticoagulants
- History of alcohol abuse or the intake of psychotropic drugs
- Pregnancy
- Infection at the injection site or a systemic infection
- Fever of unknown origin
- Motor or sensory abnormalities in the arm
Show all 11Show fewer
- Any neuromuscular disorders
- significant arthritis or other shoulder joint problems
- Any co-morbidity that interferes with this study (e.g., stroke, pace maker placement, severe ischemia, cardiac disease, etc.)
- inability to provide informed consent or follow simple instructions during experiment
- contraindications for peripheral regional anaesthesia or local an-esthetics used in the study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deltoid Muscle Contribution to Shoulder Function - An Experimental Approach
There is only one study in the literature about the quantitative effect of M. deltoideus on the movement of the shoulder. Here, the author described a 35-80% loss of abduction power after selective blockade of the N. axillaris. Gerber, on the other hand, found a loss of abduction force of 73-86% after blockade of the suprascapular nerve. These results are partly contradictory, which is why the investigators think that further investigation is needed.
For many questions in the field of shoulder orthopedics, this knowledge would provide an important additional basis for therapeutical decision-making. For example, in the treatment of rotator cuff ruptures but also in the implantation of both inverse and anatomical shoulder prostheses. Also, statements about different outcome prognoses could be made more precisely.
Read more
Therefore, the investigators would like to perform muscle strength measurements of the deltoid muscle on 12 healthy volunteers on the dominant arm.
Abduction, flexion, external rotation and internal rotation Mm. Infraspinatus, Supraspinatus and Subscapularis are tested respectively.
The investigators plan to carry out the measurements three times before and after an-anaesthesiological nerve block of the axillary nerve thus inactivating the deltoid muscle (performed exclusively by an anesthesiologist specialized in regional anesthesia). The success of the nerve block is confirmed by needle electromyographies (EMG) by a neurologist specialized in electrophysiology. Using EMG neurogenic pathologies within the tested muscles are also ruled out.
In order to exclude relevant rotator cuff pathologies the investigators will perform shoulder radiography in three planes and sonography of the rotator cuff before conducting the experiment described above.
Read the detailed description
In order to exclude relevant rotator cuff pathologies the investigators will perform plain shoulder radiography in three planes and sonography of the rotator cuff before conducting the experiment described above.
The force of abduction, flexion, external rotation and internal rotation is measured in a clinically standardized manner with a measuring device (IsoForceControl V1.1) and reported in Newton. These measurements are taken before and after the blockage of the axillary nerve, which is described below. Furthermore, before and after the blockade, an EMG of the rotator cuff and deltoid muscle will be performed in order to rule out neurogenic pathology and confirm the success of the nerve block.
Anesthesia procedure:
In the anesthesia induction area, standard monitoring (electrocardiography, blood oxygen saturation, non-invasive arterial pressure measurement) and peripheral venous access are attained and Ringer's solution will be connected to the venous access.
Axillary nerve block block (AXNB):
The AXNB is performed with the participant in the supine position using ultrasound with a 6- to 13-megahertz (MHz) linear probe.
The anesthesiologist, wearing a facemask, cap, and sterile surgical gloves after surgical hand disinfection performs skin disinfection with a two-layer application of an alcoholic povidone-iodine solution. Three minutes later, the area of the puncture point will be surrounded with sterile drapes and the ultrasound probe will be covered with a sterile cover to allow sterile skin contact.
The ultrasound probe is placed transversally in the infraclavicular region with the arm in 90° abduction. The brachial plexus and its cords are identified l lateral to the brachial artery. The posterior cord is identified by ultrasound and is blocked - or, if the axillary nerve visible too - the axillary nerve is selectively blocked when it leaves the posterior cord and lies on the subscapular muscle accompanied by the posterior circumflex humeral artery. Using an in-plane technique, a short bevel needle (UPC 90, Te-mena) connected to a nerve stimulator with the setting 0.5 milliampere (mA) current intensity, 0.1 ms impulse duration and 2 Hz impulse frequency for dual guidance, will be advanced until its tip is positioned near the nerve without eliciting motor contractions. After careful negative (for blood) aspiration local anesthetic will be applied until the targeted neuronal structure is surrounded by the injected fluid.
In the case of insufficient visualization of the nerve structures with this approach, the investigators will use a modified technique: the volunteer is placed in the sitting position, the shoulder in the neutral position but rotated 45° inward and the elbow flexed at 90° while the hand rested on the knees. Using an in-plane caudad-to-cephalad ultrasound probe placement parallel to the longitudinal axis of the shaft of the humerus and approximately 2cm below the postero-lateral part of the acromion on the dorsal side of the arm the investigators will identify the surgical neck and the shaft of the humerus and the cross section of the posterior circumflex humeral artery (PCHA), The axillary nerve is located cranially in close relation to the PCHA. The nerve will be blocked using the same material as mentioned above.All blocks will be performed by an anesthesiologist specialized in regional anesthesia (U.E. and J.A.) under standard monitoring in an anesthesia working area.
Block success is evaluated assessing the degree of sensory block (cold test) over the distribution area of the axillary nerve every 5 min. The degree of motor block will be assessed by active abduction of the arm every 5 min. After a complete axillary nerve block is documented, the electrophysiological and strength tests will be performed.
Peripheral venous line removal and participant ambulation will be performed after complete motor and sensory recovery of the hand and arm.
All participants will be assessed for neurological status of the blocked extremity by the anaesthesiologist prior to discharge and 24h after the regional anaesthesia.
A photo will be taken for documentation of the elevation function. Electromyographic studies will be performed by experienced neurologists certified in clinical neurophysiology (J.R. \& M.S.). Needle EMG serves to verify the axillary block in all three portions of the deltoid muscle, to exclude pathology in the rotator cuff muscles and concomitant anaesthesia thereof. Assessment of possible spontaneous activity, recruitment pattern and motor unit potentials will be performed according to standard methods routinely applied in clinical neurophysiology. Patients on therapeutic anticoagulation will be excluded from needle electromyographic assessments.
- Conditions
- Nerve Injury, Nerve Palsy
- Being tested
- Axillary nerve block for artificial deltoid muscle palsy
- Keywords
- muscle function, rotator cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary nerve block for artificial deltoid muscle palsyProcedure or surgery
Axillary nerve block block (AXNB):
The ultrasound probe is placed transversally in the infraclavicular region with the arm in 90° abduction. The brachial plexus and its cords are identified l lateral to the brachial artery. The posterior cord is identified by ultrasound and is blocked - or, if the axillary nerve visible too - the axillary nerve is selectively blocked when it leaves the posterior cord and lies on the subscapular muscle accompanied by the posterior circumflex humeral artery. Using an in-plane technique, a short bevel connected to a nerve stimulator with the setting 0.5 mA current intensity, 0.1 ms impulse duration and 2 Hz impulse frequency for dual guidance, will be advanced until its tip is positioned near the nerve without eliciting motor contractions. After careful negative (for blood) aspiration local anesthetic will be applied until the targeted neuronal structure is surrounded by the injected fluid.
| Study group | Role | What they receive |
|---|---|---|
| Axillary nerve block | Experimental | Axillary nerve block is performed in standardized manner and muscle force is measured before and after the block. Receives: Procedure: Axillary nerve block for artificial deltoid muscle palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength of the rotator cuff
Strength of abduction, flexion, external rotation and internal rotation in Mm. infraspinatus, supraspinatus and subscapularis respectively measured in Newton before and after blockade of the N. axillaris.
Measured: 6 hours
Secondary outcomes (1)
Geometric shoulder data
Analysis of the geometric data of the X-ray images and correlation with the primary outcome.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 May 2019
- Primary completion30 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve InjuryStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881462
- Sponsor's protocol ID
- ID 2019-00135
- Status last verified
- Aug 2019
- First submitted
- 15 Feb 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deltoid Muscle Contribution to Shoulder Function - An Experimental Approach
- ClinicalTrials.gov ID
- NCT03881462
- Acronym / sponsor ID
- ID 2019-00135
- Conditions
- Nerve Injury, Nerve Palsy
- Keywords
- muscle function, rotator cuff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 19 Mar 2019 (actual)
- 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.
There is only one study in the literature about the quantitative effect of M. deltoideus on the movement of the shoulder. Here, the author described a 35-80% loss of abduction power after selective blockade of the N. axillaris. Gerber, on the other hand, found a loss of abduction force of 73-86% after blockade of the suprascapular nerve. These results are partly contradictory, which is why the investigators think that further investigation is needed.
For many questions in the field of shoulder orthopedics, this knowledge would provide an important additional basis for therapeutical decision-making. For example, in the treatment of rotator cuff ruptures but also in the implantation of both inverse and anatomical shoulder prostheses. Also, statements about different outcome prognoses could be made more precisely.
Therefore, the investigators would like to perform muscle strength measurements of the deltoid muscle on 12 healthy volunteers on the dominant arm.
Abduction, flexion, external rotation and internal rotation Mm. Infraspinatus, Supraspinatus and Subscapularis are tested respectively.
The investigators plan to carry out the measurements three times before and after an-anaesthesiological nerve block of the axillary nerve thus inactivating the deltoid muscle (performed exclusively by an anesthesiologist specialized in regional anesthesia). The success of the nerve block is confirmed by needle electromyographies (EMG) by a neurologist specialized in electrophysiology. Using EMG neurogenic pathologies within the tested muscles are also ruled out.
In order to exclude relevant rotator cuff pathologies the investigators will perform shoulder radiography in three planes and sonography of the rotator cuff before conducting the experiment described above.
Detailed description
In order to exclude relevant rotator cuff pathologies the investigators will perform plain shoulder radiography in three planes and sonography of the rotator cuff before conducting the experiment described above.
The force of abduction, flexion, external rotation and internal rotation is measured in a clinically standardized manner with a measuring device (IsoForceControl V1.1) and reported in Newton. These measurements are taken before and after the blockage of the axillary nerve, which is described below. Furthermore, before and after the blockade, an EMG of the rotator cuff and deltoid muscle will be performed in order to rule out neurogenic pathology and confirm the success of the nerve block.
Anesthesia procedure:
In the anesthesia induction area, standard monitoring (electrocardiography, blood oxygen saturation, non-invasive arterial pressure measurement) and peripheral venous access are attained and Ringer's solution will be connected to the venous access.
Axillary nerve block block (AXNB):
The AXNB is performed with the participant in the supine position using ultrasound with a 6- to 13-megahertz (MHz) linear probe.
The anesthesiologist, wearing a facemask, cap, and sterile surgical gloves after surgical hand disinfection performs skin disinfection with a two-layer application of an alcoholic povidone-iodine solution. Three minutes later, the area of the puncture point will be surrounded with sterile drapes and the ultrasound probe will be covered with a sterile cover to allow sterile skin contact.
The ultrasound probe is placed transversally in the infraclavicular region with the arm in 90° abduction. The brachial plexus and its cords are identified l lateral to the brachial artery. The posterior cord is identified by ultrasound and is blocked - or, if the axillary nerve visible too - the axillary nerve is selectively blocked when it leaves the posterior cord and lies on the subscapular muscle accompanied by the posterior circumflex humeral artery. Using an in-plane technique, a short bevel needle (UPC 90, Te-mena) connected to a nerve stimulator with the setting 0.5 milliampere (mA) current intensity, 0.1 ms impulse duration and 2 Hz impulse frequency for dual guidance, will be advanced until its tip is positioned near the nerve without eliciting motor contractions. After careful negative (for blood) aspiration local anesthetic will be applied until the targeted neuronal structure is surrounded by the injected fluid.
In the case of insufficient visualization of the nerve structures with this approach, the investigators will use a modified technique: the volunteer is placed in the sitting position, the shoulder in the neutral position but rotated 45° inward and the elbow flexed at 90° while the hand rested on the knees. Using an in-plane caudad-to-cephalad ultrasound probe placement parallel to the longitudinal axis of the shaft of the humerus and approximately 2cm below the postero-lateral part of the acromion on the dorsal side of the arm the investigators will identify the surgical neck and the shaft of the humerus and the cross section of the posterior circumflex humeral artery (PCHA), The axillary nerve is located cranially in close relation to the PCHA. The nerve will be blocked using the same material as mentioned above.All blocks will be performed by an anesthesiologist specialized in regional anesthesia (U.E. and J.A.) under standard monitoring in an anesthesia working area.
Block success is evaluated assessing the degree of sensory block (cold test) over the distribution area of the axillary nerve every 5 min. The degree of motor block will be assessed by active abduction of the arm every 5 min. After a complete axillary nerve block is documented, the electrophysiological and strength tests will be performed.
Peripheral venous line removal and participant ambulation will be performed after complete motor and sensory recovery of the hand and arm.
All participants will be assessed for neurological status of the blocked extremity by the anaesthesiologist prior to discharge and 24h after the regional anaesthesia.
A photo will be taken for documentation of the elevation function. Electromyographic studies will be performed by experienced neurologists certified in clinical neurophysiology (J.R. \& M.S.). Needle EMG serves to verify the axillary block in all three portions of the deltoid muscle, to exclude pathology in the rotator cuff muscles and concomitant anaesthesia thereof. Assessment of possible spontaneous activity, recruitment pattern and motor unit potentials will be performed according to standard methods routinely applied in clinical neurophysiology. Patients on therapeutic anticoagulation will be excluded from needle electromyographic assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axillary nerve block | Experimental | Procedure: Axillary nerve block for artificial deltoid muscle palsyAxillary nerve block is performed in standardized manner and muscle force is measured before and after the block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of anesthesiologists (ASA) classification I - II, both sexes
- ≥ 18 years old
- < 65 years old
- Written informed consent as documented by signature
Key exclusion criteria (11 listed)
- Severe coagulopathy or intake of anticoagulants
- History of alcohol abuse or the intake of psychotropic drugs
- Pregnancy
- Infection at the injection site or a systemic infection
- Fever of unknown origin
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 |
|---|---|---|
| Axillary nerve block for artificial deltoid muscle palsyAxillary nerve block block (AXNB): The ultrasound probe is placed transversally in the infraclavicular region with the arm in 90° abduction. The brachial plexus and its cords are identified l lateral to the brachial artery. The posterior cord is identified by ultrasound and is blocked - or, if the axillary nerve visible too - the axillary nerve is selectively blocked when it leaves the posterior cord and lies on the subscapular muscle accompanied by the posterior circumflex humeral artery. Using an in-plane technique, a short bevel connected to a nerve stimulator with the setting 0.5 mA current intensity, 0.1 ms impulse duration and 2 Hz impulse frequency for dual guidance, will be advanced until its tip is positioned near the nerve without eliciting motor contractions. After careful negative (for blood) aspiration local anesthetic will be applied until the targeted neuronal structure is surrounded by the injected fluid. | Procedure or surgery | Axillary nerve block |
Primary outcome
Muscle strength of the rotator cuff
Time frame: 6 hours
Strength of abduction, flexion, external rotation and internal rotation in Mm. infraspinatus, supraspinatus and subscapularis respectively measured in Newton before and after blockade of the N. axillaris.
1 secondary outcome
Geometric shoulder data
Time frame: 15 minutes
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 14 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary nerve block for artificial deltoid muscle palsy in people with Nerve Injury and Nerve Palsy, run by Balgrist University Hospital at 1 site in Switzerland.
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 11 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 14 Jan 2020. 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 Switzerland. 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?
Muscle strength of the rotator cuff (time frame: 6 hours). 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 14 Jan 2020.