"Incidence and Etiology of Complications Associated With Regional Anesthesia of Peripheral Nerves: a Prospective Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,390
- 试验地点
- 1
- 主要终点
- rate of complications of peripheral nerve blocks
研究概览
简要总结
Procedures performed under regional anesthesia, especially peripheral nerve blocks (PNB) have increased markedly in recent decades. However, like any technical procedure, these techniques carry an implicit risk of complications.
The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain.
详细描述
Introduction. The number of procedures performed under regional anesthesia, especially peripheral nerve blocks (BNP) have increased notably in recent decades due to the improvement in pain control and the quality of post-anesthetic recovery that they provide. However, like any technical procedure, these techniques carry an implicit risk of complications.
Purpose. The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain.
Material and methods. The postoperative results regarding the complications of regional anesthesia of peripheral nerves will be evaluated in a national audit of a prospective observational cohort in which hospitals at the state level in which these regional techniques are routinely performed will participate. A minimum sample size has been calculated on a population of 100,000 patients and a 95% confidence interval of 1,390, assuming a complication rate of 0.2% based on previous publications.
Inclusion criteria correspond to patients older than 18 years scheduled for surgery with a peripheral regional anesthesia technique as the basis of anesthesia or as part of a multimodal analgesic strategy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •ASA I- IV
- •Being scheduled for surgery with peripheral and/or fascial nerve blocks as the basis of anesthesia or as part of a multimodal analgesic strategy.
排除标准
- •Refusal of the patient to participate in the study
- •Contraindication for performing the regional technique (People with infections in the area of the skin where the puncture must be performed, allergy to anesthetics, severe blood coagulation disorders, previous nerve damage).
- •Motor or sensory deficit prior to surgery in the metameric area susceptible to performing the block.
结局指标
主要结局
rate of complications of peripheral nerve blocks
时间窗: 2 years
The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain
次要结局
- Etiology(2 years)
- Number of Factors related(2 years)
研究者
María Teresa Fernandez
Fernandez,Maria Teresa, MD, Principal investigator
Hospital del Rio Hortega