Autologous Blood Transfusion After Local Infiltration
Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty
Total knee and hip arthroplasty for osteoarthritis is performed on still broader indications even in elderly patients with previous or current medical conditions. Especially comorbidity like cardiovascular diseases and conditions with increased risk of bleeding or previous thrombo-embolic events are major challenges.
To facilitate safe use of ropivacaine as an analgesic, information on the concentrations levels after autologous blood transfusion following local infiltration analgesia is very crucial. However, very limited data are available. To verify the safety of autologous blood transfusion, ropivacaine concentrations were studied in 52 patients undergoing either total knee arthroplasty or total hip arthroplasty.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Aalborg、丹麦
- Vendsyssel Hospital, Frederikshavn, Aalborg Hospital, Aarhus University
-
-
参与标准
资格标准
适合学习的年龄
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:
- Clinical diagnosis for hip arthroplasty
- Clinical diagnosis for knee arthroplasty
Exclusion Criteria:
- Patients < 18 years
- Lack of informed consent
- Inability to read/understand Danish
- Bilateral diagnosis
- Cancer diagnosis
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:追溯
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Total knee arthroplasty
25 consecutive patients diagnosed for total knee arthroplasty.
|
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
其他名称:
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
其他名称:
|
|
Total hip arthroplasty
27 patients diagnosed for total hip arthroplasty.
|
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
其他名称:
Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
其他名称:
|
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 |
|---|---|---|
|
Concentrations of ropivacaine in serum
大体时间:6 hours
|
Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.
|
6 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Analysis of ECG and pulse rate
大体时间:6 hours
|
ECG, pulse rate and blood pressure will be analyzed in proportion to concentrations of serum before and after autologous blood transfusion
|
6 hours
|
合作者和调查者
调查人员
- 首席研究员:Ole Simonsen, M.D.、Northern Orthopaedic Department, Aalborg University Hospital, Denmark
- 学习椅:Sten Rasmussen, M.D.、Northern Orthopaedic Division, Aalborg University Hospital, Denmark
- 学习椅:Bjarne B. Dencker, M.D.、Department of Anaesthesiology, Aalborg University Hospital, Denmark
- 学习椅:Torben Breindahl, M.D.、Department of Clinical Biochemistry, Vendsyssel Hospital, Aarhus University, Denmark
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.