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临床试验/NCT00421967
NCT00421967终止4 期

Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion

University of Aarhus1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年1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
终止
入组人数
80
试验地点
1
主要终点
Analgésia consumption

研究概览

简要总结

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.

The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.

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
None

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

  • Patients admitted consecutively to primary total knee arthroplasty.
  • Provided informed consent

排除标准

  • Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
  • Severe chronic neurogenic pain
  • Medical treated diabetes
  • Contraindications for spinal aesthesia and epidural analgesia
  • Known hypersensitivity towards study drugs
  • Rheumatoid arthritis
  • Treatment with narcotics
  • Treatment with antidepressants
  • Severe obesity BMI>35
  • Treatment with antacid
  • Not able to speak and understand Danish

研究组 & 干预措施

1

Experimental

干预措施: Ropivacaine, Ketorolac, adrenaline (Drug)

2

Active Comparator

干预措施: Ropivacaine Ketorolac (Drug)

结局指标

主要结局

Analgésia consumption

时间窗: 48 h

次要结局

  • Time to discharge
  • Cytokine level(48 h)
  • Pain scores VAS(72 h)
  • Side-effects(72 h)

研究者

申办方类型
Other

研究点 (1)

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Postoperative Analgesia After Total Knee Arthroplasty | 临床试验