此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine

2010年7月7日 更新者:United Christian Hospital

Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain relief technique after having total knee replacement operation(1,4). Patient controlled epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2) and results in reduced epidural analgesic requirements(3). Besides, it also bear the advantage of avoidance of overdose, reduction of waiting times and involvement of patients in their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic using in epidural analgesia which has been proven to be safe and effective(4). 0.2% Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong, which has been proved to be safe, effective and may be better value for money. These two drugs has been proven to have similar analgesic potency in using as EA for postoperative pain relief for other operation(5,6,7) and for orthropaedics operation but in different concentration(4). Concerns have been raised about the introduction of the levobupivacaine in the departmental protocol. Objectives of this study are A)to determine the equivalence of two local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens.

The null hypothesis is that the difference of analgesic effect, presented with visual analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the threshold of 9 mm VAS. (8,9,10)

研究概览

研究类型

介入性

注册 (预期的)

60

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hong Kong、香港
        • 招聘中
        • United Christian Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • > 18 years old, ASA I -III and
  • Undergoing total knee arthroplasty
  • Combine spinal-epidural anaesthesia

Exclusion Criteria:

  • Known hypersensitivity to amide-type local anaesthetics
  • Known hypersensitivity to opioids
  • Known history of severe cardiovascular, renal, hepatic, neurological or psychiatric disease as judged by the investigator
  • Known history of peripheral neuropathies
  • Those receiving chronic analgesic therapy, or any contraindication for epidural analgesia (e.g. clotting disorders, or history of lumbar surgery)
  • Inability to perform a pain score, or pregnancy or lactation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Levobupivacaine
patient control epidural analgeisa using 0.2% levobupivacaine with 2ug/ml fentanyl
patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl
有源比较器:Ropivacaine
patient controlled epidural analgesia using 0.2% ropivacaine with 2ug/ml fentanyl
patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl

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
Pain score
大体时间:48hours after start epidural analgesia
as well as complications from epidural analgesia are also going to record and monitored
48hours after start epidural analgesia

次要结果测量

结果测量
大体时间
cost/treatment
大体时间:48hours
48hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • Reference 1. Block et al. Efficiancy of postoperative epidural analgesia: A meta-analysis. JAMA 290: 2455-63 2. Werawatganon T. Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. The Cochrane Databas of systemic reviews. Issue 3 Art. No.: No.: CD 004044. DOI: 10.1002/14651858. CD004088.pub2. 3. Liu SS et al. Patient-controlled epidural analgesia with bupivacaine and fentanyl on hospital wards: propective experience with 1,030 surgical patients Anesthesiology 88: 388-95 4. Silvasti M et al. Patient-controlled analgesia versus continuous epidural analgesia after total knee arthroplasty Acta Anaesthesiol Scand 42: 576 - 80 5. Stand T et al. Patient-controlled epidural analgesia reduces analgesic requirements compared to continuous epidural infusion after major abdominal surgery. Can J Anaesth 50:258-64 6. Linda S. et al. Relative Analgesic Potencies of Levobupivacaine and Ropivacaine for Epidural Analgesia in Labor. Anesthesiology 2003; 99:1354-8 7. Marc Senard et al. Epidural Levobupivacaine 0.1% or Ropivacaine 0.1% Combined with Morphine Provides Comparable Analgesia After Abdominal Surgery Anesth Analg 2004;98:389-94 8. Kelly AM The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain.Emerg Med J 2001; 18:205-07 9. Mark MSM et al. The minimum clinically significant difference in visual analogue scale pain score in a local emergency setting. Hong Kong Journal of Emergency Medicine 2009; 16(4): 234-6 10. Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov; 5(11): 1086-90.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年4月1日

初级完成 (预期的)

2010年9月1日

研究完成 (预期的)

2010年12月1日

研究注册日期

首次提交

2010年7月7日

首先提交符合 QC 标准的

2010年7月7日

首次发布 (估计)

2010年7月8日

研究记录更新

最后更新发布 (估计)

2010年7月8日

上次提交的符合 QC 标准的更新

2010年7月7日

最后验证

2010年2月1日

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.

订阅