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临床试验/NCT01576263
NCT01576263已完成不适用

Autologous Blood Transfusion After Local Infiltration Analgesia With Ropivacaine in Total Knee and Hip Arthroplasty

Northern Orthopaedic Division, Denmark1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Concentrations of ropivacaine in serum

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis for hip arthroplasty
  • Clinical diagnosis for knee arthroplasty

排除标准

  • Patients < 18 years
  • Lack of informed consent
  • Inability to read/understand Danish
  • Bilateral diagnosis
  • Cancer diagnosis

研究组 & 干预措施

Total knee arthroplasty

25 consecutive patients diagnosed for total knee arthroplasty.

干预措施: Autologous blood transfusion with ropivacaine (Drug)

Total hip arthroplasty

27 patients diagnosed for total hip arthroplasty.

干预措施: Autologous blood transfusion with ropivacaine (Drug)

结局指标

主要结局

Concentrations of ropivacaine in serum

时间窗: 6 hours

Concentrations of ropivacaine in serum before and after autologous blood transfusion will be analyzed.

次要结局

  • Analysis of ECG and pulse rate(6 hours)

研究者

发起方
Northern Orthopaedic Division, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (1)

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