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临床试验/NCT02272660
NCT02272660已完成4 期

Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2014年10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
入组人数
74
试验地点
1
主要终点
To evaluate the Morphine consumption in each group patients

研究概览

简要总结

Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

详细描述

Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management.

We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA).
  • Age between 18-65 years.
  • Chinese ethnicity.

排除标准

  • patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma.
  • patient exhibited allergy to parecoxib sodium.
  • lactating or pregnant.
  • any other conditions not suitable for surgery as evaluated by the surgeon in charge.

研究组 & 干预措施

Parecoxib sodium

Experimental

The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision.

干预措施: Parecoxib sodium (Drug)

Normal saline injection

Placebo Comparator

The control group received 2 mL normal saline injection at the same time point.

干预措施: Normal saline injection (Drug)

结局指标

主要结局

To evaluate the Morphine consumption in each group patients

时间窗: 4 hours to 6 days after the surgery

次要结局

  • To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration(4 hours to 6 days after the surgery)
  • To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty(4 hours to 6 days after the surgery)
  • Function recovery of knee Range of Motion (ROM) for patients received surgery(3 and 6 days after the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhihong Wu

Prof

Peking Union Medical College Hospital

研究点 (1)

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