NCT03881462

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

January 14, 2020

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

February 15, 2019

Last Update Submit

January 12, 2020

Conditions

Keywords

muscle functionrotator cuff

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 hours

Secondary Outcomes (1)

  • Geometric shoulder data

    15 minutes

Study Arms (1)

Axillary nerve block

EXPERIMENTAL

Axillary nerve block is performed in standardized manner and muscle force is measured before and after the block.

Procedure: Axillary nerve block for artificial deltoid muscle palsy

Interventions

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.

Axillary nerve block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of anesthesiologists (ASA) classification I - II, both sexes
  • ≥ 18 years old
  • \< 65 years old
  • Written informed consent as documented by signature

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

March 19, 2019

Study Start

May 1, 2019

Primary Completion

July 30, 2019

Study Completion

September 30, 2019

Last Updated

January 14, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations