Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane
赞助:
Balgrist University Hospital
合作者:
信息的提供 (责任方):
Konstantinos Kalimeris，Balgrist University Hospital
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | June 27, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 7, 2018 | ||
| 预计主要完成日期 | April 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Dislocation of the femoral nerve catheter at 48 hours after its placement.[ Time Frame: 48 hours after the placement of the catheter ] The catheter will be checked if in the right place |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane | ||
| 正式标题 ICMJE | Dislocation Rates of Femoral Catheter Placed Sonographically Either In-plane or Out-of-plane: A Prospective Randomized Study | ||
| 简要概况 | Dislocation of the femoral nerve catheters, which are used as postoperative analgesic method after knie surgery, will be studied. Two Groups will be compared; in the first group the femoral nerve catheter will be placed sonographically with the in-plane technique, whereas in the other Group the femoral nerve catheter will be placed sonographically with the out-of-plane technique |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 4 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 1 Group will be compared to another 盲法: Interventional 盲法描述:The Patient will not be told in which Group he belongs 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
80 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | July 2019 | ||
| 预计主要完成日期 | April 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: American Society of Anesthesiologists class I-III patients, both sexes ≥ 18 years old - Patients are undergoing major knie surgery at our University Hospital with standard use of regional anesthesia techniques to provide analgesia Exclusion Criteria: - Contraindications or allergy to the use of local anesthetics or other drugs used in the study. - Women who are pregnant or breast feeding - Women who have the intention to become pregnant during the course of the study - Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator(s) in individual cases - Patients with acute porphyria - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant - Participation in another study with investigational drug within the 30 days preceding and during the present study - Previous enrollment into the current study - BMI > 40 - Local inflammation in the inguinal area - Patient refusal for regional anesthesia or participation in the study - Enrollment of the investigator, his/her family members, employees and other dependent persons | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Konstantinos Kalimeris，Balgrist University Hospital | ||
| 研究赞助商 ICMJE | Balgrist University Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Balgrist University Hospital | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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