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临床试验/NCT01304212
NCT01304212已完成4 期

Comparison of the Analgesic Effect of Femoral Nerve Block, Intraarticular Infiltration or a Combination of Both in the Control of Pain in Total Knee Arthroplasty

Jose Antonio Bernia Gil1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
137
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

The purpose of this study is to compare the analgesic effectiveness of three techniques: the femoral nerve block, intraarticular infiltration or a combination of both in the control of pain in total knee arthroplasty (KA). The hypothesis to be tested in this study is that the performance multimodal postoperative pain KA combining two analgesic techniques to obtain better analgesia than when applied separately.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • intervention program for total knee arthroplasty
  • ASA I, II, III
  • over 65 years old

排除标准

  • ASA > III
  • patients who refuse the realization of technical loco-regional anesthesia
  • presence of coagulopathy or impaired hemostatic function
  • BMI > 35
  • Serious intraoperative complications
  • patients undergoing bypass and aortic-femoral or femoro popliteal bypass operated leg
  • patients treated for chronic pain diagnosed processes, different knee osteoarthritis

研究组 & 干预措施

femoral block

Active Comparator

干预措施: ropivacaine (Drug)

local infiltration + femoral nerve block

Experimental

Combination of local infiltration with drugs and femoral nerve block

干预措施: morphine ,ketorolac (Drug)

several drugs local infiltration

Active Comparator

干预措施: ropivacaine,morphine chloride,epinephrine,ketorolac (Drug)

结局指标

主要结局

postoperative pain

时间窗: 48 hours postoperatively

Is measured at the time of starting rehabilitation, postoperatively 48 hours using visual analog scale, numerical and categorical verbal pain scale at 12,24 and 48 hours

次要结局

未报告次要终点

研究者

发起方
Jose Antonio Bernia Gil
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jose Antonio Bernia Gil

PhD,MD

Consorci Sanitari de Terrassa

研究点 (1)

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Effectiveness of Analgesia in Total Knee Arthroplasty | 临床试验