跳至主要内容
临床试验/NCT04626869
NCT04626869已完成4 期

Anterior Suprascapular Nerve Block is as Effective as Interscalene Nerve Block and Causes Less Diapragm Paralysis in Arthroscopic Shoulder Surgery

Alper Tunga Dogan2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Pain rating

研究概览

简要总结

Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region.

The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis.

详细描述

Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. More distal brachial plexus blocks have been defined to avoid diaphragmatic paralysis . Thus, it is aimed to apply the local anesthetic drug further from the phrenic nerve. With the application of ultrasound, the amount of local anesthetic drug was reduced to less than 20 ml.

There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region. Although it has been shown in a cadaver study that the phrenic nerve can be stained after anterior suprascapular nerve block, the clinical effect is not fully known.

The effect of continuous local anesthetic drug administration on respiratory muscles through catheters placed in the peripheral nerve is another matter of concern. The method that will not affect the phrenic nerve at all and at the same time provide an effective analgesia is still under investigation.

The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis. One of the questions that our research aims to answer is how the continuous application of local anesthetic drugs affects the diaphragm muscle with the insertion of catheters in both regions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Diaphragm Measurements will be done by an expert unaware of the working groups.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > 18 years old
  • American Society of Anesthesiology (ASA) score of 1-3
  • Scheduled for elective surgery.

排除标准

  • Patients with a condition that prevents peripheral nerve block
  • Coagulopathies
  • Chronic opioid use
  • Polyneuropathy
  • Cognitive dysfunction
  • Communication difficulties
  • Allergies to drugs used

结局指标

主要结局

Pain rating

时间窗: Postoperative 12 hours

Measured by VAS. Postoperative 12 hours

次要结局

  • Diaphragmatic movements(At the first postoperative 24 hours)

研究者

发起方
Alper Tunga Dogan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alper Tunga Dogan

Anesthesiology specialist

V.K.V. American Hospital, Istanbul

研究点 (2)

Loading locations...

相似试验

Anterior Suprascapular Nerve Block is an Effective... | 临床试验