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临床试验/NCT00616850
NCT00616850撤回不适用

Treatment of Postoperative Pain After Total Knee Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia Versus Continuous Femoral Block Catheter in Combination With Patient Controlled Analgesia: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.

Loma Linda University1 个研究点 分布在 1 个国家开始时间: 2007年10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
撤回
试验地点
1
主要终点
Total PCA opioid consumption

研究概览

简要总结

Total knee replacement is often associated with severe postoperative pain, especially in the first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use opioids. Opioids are excellent painkillers but their use is hampered by side effects such as nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to PCAs will lower the amount of opioids that these patients receive, thereby improving patient safety while still providing adequate analgesia. In addition, continuous femoral block has been shown to provide superior postoperative pain control when compared to morphine PCA. Therefore, postoperative pain levels of study subjects will be compared to those subjects who receive a combination of a continuous femoral block catheter with a PCA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing a total knee arthroplasty
  • Be American Society of Anesthesiologist physical status 1,2, or 3
  • Be willing and capable of providing informed consent
  • Be English speaking

排除标准

  • Age greater than 80 years old or younger than 18 years old
  • Congestive hear failure
  • Hepatic insufficiency
  • Neurological disorders
  • Psychiatric disorders
  • Steroid treatment
  • History of atrial fibrillation
  • Chronic pain disorder with opioid treatment

研究组 & 干预措施

Group B

Experimental

Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.

干预措施: Lidocaine (Drug)

Group A

Active Comparator

Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).

干预措施: Continuous femoral catheter block (Procedure)

Group C

Placebo Comparator

Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.

干预措施: Preservative free normal saline (Other)

结局指标

主要结局

Total PCA opioid consumption

时间窗: 72 hours

次要结局

  • Time to first flatus(72 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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