RICALOR - Registro Italiano Complicanze Anestesia LOco Regionale - Italian Registry for Complications During Regional Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63,692
- 试验地点
- 1
- 主要终点
- number of subjects presenting complications associated with regional anesthesia techniques
研究概览
简要总结
Regional anesthesia is the cornerstone of modern postoperative analgesia, but concerns remain about possible adverse effects and complication.
RICALOR Group Investigators developed a national registry to register the incidence of regional anesthesia-associated complications and to identify possible risk factors.
详细描述
The project has been advertised through direct contact with relevant organizations in anaesthesia and pain management. Any other center willing to participate is provided with all the documents to receive its local Institutional Review Board (IRB) approval, and a 'local responsible' (LR) is nominated to co-ordinate the project and to be responsible of data collection locally.
Centers receiving IRB approval collect data about different types of procedure (adult major and minor surgery, pediatric surgery, obstetric anesthesia, pain management). Data are collected on a specifically designed form, and every center quarterly sent the promoter centre a report including general data and a specific report for every occurred complication.
Eligibility criteria
Investigators collect the total number of intervention and the number of regional anesthesia(RA) techniques performed . Patients recorded as "case" and "controls" had to sign a specifical informed consent. For pediatric patients and patients not able to sign for any reason, a specific form is included in the document, to be signed by parents or any legally-established tutor, as required for every clinical procedure or scientific trial in our country.
General data
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing surgery or procedures needing regional anesthesia
- •signed informed consent for data treatment
排除标准
- •no informed consent
结局指标
主要结局
number of subjects presenting complications associated with regional anesthesia techniques
时间窗: 6 months
Number of subjects presenting complications associated with regional anesthesia is recorded, and when a neurologic deficit could occur, we monitor the patient for at least 6 months
次要结局
- statistically significant difference in cases (complication) and controls regarding factors potentially affecting complications' occurrence(up to dismission)
研究者
Massimo Allegri
MD
Fondazione IRCCS Policlinico San Matteo di Pavia