Nerve Injury Clinical Trial
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.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT01437332 -
Molecular Mediators of Nerve Injury Signaling
|
N/A | |
Completed |
NCT03624426 -
Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery
|
N/A | |
Recruiting |
NCT04662320 -
Promoting Healing Of Nerves Through Electrical Stimulation
|
N/A | |
Recruiting |
NCT04144972 -
Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain
|
N/A | |
Completed |
NCT02960516 -
MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
|
||
Completed |
NCT05589324 -
Effects of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury
|
||
Recruiting |
NCT03970161 -
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
|
N/A | |
Completed |
NCT01533337 -
Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits
|
N/A | |
Completed |
NCT01528397 -
Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft
|
N/A | |
Enrolling by invitation |
NCT05080608 -
Nerve Injury in the Hand, an Interview Study
|
||
Completed |
NCT05302141 -
Effects of Assistive Device on ADL Function in Patients With Nerve Injury
|
N/A | |
Terminated |
NCT01751503 -
Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer
|
N/A | |
Recruiting |
NCT05365282 -
Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
|
||
Active, not recruiting |
NCT03701581 -
4-aminopyridine Treatment for Nerve Injury
|
Phase 2/Phase 3 | |
Withdrawn |
NCT04270019 -
Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration
|
Phase 1/Phase 2 | |
Completed |
NCT04420689 -
A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery
|
Phase 1/Phase 2 | |
Recruiting |
NCT05884125 -
Promoting Healing of Injured Nerves With Electrical Stimulation Therapy
|
N/A | |
Recruiting |
NCT05611983 -
Experience and Feasibility of Methods for Early Sensory Training
|
N/A | |
Completed |
NCT02032030 -
Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys
|
||
Completed |
NCT03701685 -
A Comparison of the Littler Flap With the Bipedicled Nerve Flap
|
N/A |