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临床试验/NCT03881462
NCT03881462已完成不适用

Deltoid Muscle Contribution to Shoulder Function - An Experimental Approach

Balgrist University Hospital2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Muscle strength of the rotator cuff

研究概览

简要总结

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.

详细描述

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):

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Muscle strength of the rotator cuff

时间窗: 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.

次要结局

  • Geometric shoulder data(15 minutes)

研究者

发起方
Balgrist University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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