RICALOR Italian Registry for Complications During Regional Anesthesia (RICALOR)
RICALOR - Registro Italiano Complicanze Anestesia LOco Regionale - Italian Registry for Complications During Regional Anesthesia
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.
研究概览
详细说明
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
Total number of interventions, the number of central neuraxial block (CNBs), peripheral nerve blocks (PNBs) and continuous PNBs (CPNBs) performed. CNBs are classified as epidurals, combined spinal-epidurals (CSEs), subarachnoid. PNBs and cPNBs are divided into ultrasound-guided, nerve stimulation-guided and blind techniques.
Specific data - report for complications
For each complication a specific report is sent for data analysis, including data concerning cases (patient with complication) and controls (the two following patients undergoing the same type of loco-regional technique).
Reports are slightly different for CNBs and (c)PNBs. For every patient, the investigators register demographic data (age, ASA-American Society of Anesthesiologists- status, height and weight), data regarding surgical technique (type of surgery, open/video-laparoscopic/robotic approach, election/emergency surgery) and data regarding anti-thromboembolic therapy (drugs, timing of suspension before/after blockade).
A second part of the report is strictly dedicated to the technique and to the type of complication occurred (and, hence, different in central and peripheral blocks).
Statistical analysis
Study population is estimated basing on previous studies of major complications after CNBs, which indicate an incidence of major adverse effects of 4.2 on 100.000 patients. Estimating an incidence of 1:25.000, a number of 25.000 procedures was calculated to be needed for the study, with a confidence interval of 95%. The primary endpoint was to assess cumulative incidence of adverse effects, while a following case-control analysis will be performed to identify possible risk factors.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Pavia、意大利、27100
- IRCCS Policlinico S Matteo
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- M/F
- undergoing surgery or procedures needing regional anesthesia
- signed informed consent for data treatment
Exclusion Criteria:
- no informed consent
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
---|---|
regional anesthesia
patients undergoing regional anesthesia procedures
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Spinal, epidural, combined spinal epidural, nerve blocks
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
number of subjects presenting complications associated with regional anesthesia techniques
大体时间: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
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6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
statistically significant difference in cases (complication) and controls regarding factors potentially affecting complications' occurrence
大体时间:up to dismission
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Case control analysis to identify risk factors connected with major complications.
Analyzed variables will be: demographic variables, emergency/election surgery, equipment (needles, type of guidance), tourniquet, patients position, drugs dosing regimen, anti-thrombotic therapy, type of surgery, operator experience, type of block.
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up to dismission
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合作者和调查者
出版物和有用的链接
一般刊物
- Bugada Dario; Allegri Massimo; RICALOR Group investigators; Zadra Nicola; Braschi Antonio ; Borghi Battista; Grossi Paolo.
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.