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临床试验/NCT06460792
NCT06460792招募中不适用

The Quality of Ultrasound-guided Peripheral Nerve Blocks, Nerve Injury, Bleeding Complications and Learning - a Prospective Observational Cohort Study

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Block Success

研究概览

简要总结

Peripheral nerve blocks are often used in anaesthesia. They can be used as the only method of anaesthesia during surgery or in combination with other methods, e.g., general anaesthesia and sedation. Moreover, peripheral nerve blocks are used to treat postoperative pain, alleviate pain in trauma patients, and for painful procedures.

For a method to be clinically useful, it is essential to understand the factors contributing to high success rates. It is equally important to know the complications related to the method. Finally, it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance. Therefore, we aim to establish a prospective and ongoing database to gain insight into 1) Factors contributing to block quality, e.g., success rate and nerve block duration; 2) Frequencies and types of nerve injuries and bleeding complications associated with the block procedure; 3) Tracking of block performance by anaesthesiologists.

详细描述

Introduction Peripheral nerve blocks are often used in anaesthesia. They can be used as the only method of anaesthesia during surgery or in combination with other methods, e.g., general anaesthesia and sedation. Moreover, peripheral nerve blocks are used to treat postoperative pain, alleviate pain in trauma patients, and for painful procedures.

For a method to be clinically useful, it is essential to understand the factors contributing to high success rates. It is equally important to know the complications related to the method. Finally, it is essential to establish a robust learning system where the anesthesiologists can track their nerve block performance over time and compare it to high performers and general performance. Therefore, we aim to establish a prospective and ongoing database to gain insight into 1) Factors contributing to block quality, e.g., success rate and nerve block duration; 2) Frequencies and types of nerve injuries and bleeding complications associated with the block procedure; 3) Tracking of block performance by anaesthesiologists. These three points are described in more detail below:

  1. Success rate (block quality) It is difficult to get an overview of the success rates of peripheral nerve blocks. Most studies focus on one specific nerve block, and the number of included patients is often low. In addition, the block procedure is performed by a few anaesthesiologists who are highly skilled in the specific procedure. By establishing a database, including the most used peripheral nerve blocks used in different settings, i.e., surgery, perioperative pain management, and painful procedures, and by including anaesthesiologists with varying levels of experience and expertise, it will be possible to get a more detailed picture of factors that are important for achieving high success rates.
  2. Complications Nerve injury. Peripheral nerve blocks are generally considered safe to use with low complication rates. However, complications can be severe and result in permanent nerve injury. Therefore, it is essential to get an overview of block-related complications and factors associated with these complications. Different regions have specific characteristics, and complications probably follow a characteristic pattern. A database with sufficient data will allow us to detail essential factors for understanding how complications develop and turn into permanent injuries.

Bleeding. Today, many patients receive anticoagulant therapy. We will, therefore, collect data on bleeding complications associated with the block procedure. 3. Learning Ultrasound-guided peripheral nerve blocks require a certain amount of skill to deposit LA in the correct place. By gathering data on block quality from individual anaesthesiologists over time it will be possible to gain insight into learning curves and factors important for learning different block procedures.

Methods Study design: Observational prospective cohort study. Setting: Initially, a single-centre study at the Department of Anaesthesiology, North Zealand Hospital. We envision to include as many centres as possible in Denmark.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 2 years
  • Exclusion Criteria
  • Infection at puncture site
  • Allergy to local anesthetics
  • Unable to understand given oral instruction

排除标准

  • 未提供

结局指标

主要结局

Block Success

时间窗: 2 hours

Clinical evaluation of nerve function

次要结局

未报告次要终点

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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