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临床试验/NCT06815445
NCT06815445已完成不适用

Postoperative Pain and Blood Loss of Non-use Compared to Partial-use of a Tourniquet in Bilateral Total Knee Replacement: A Randomized- Control Trial

Queen Savang Vadhana Memorial Hospital, Thailand1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

Postoperative pain and blood loss of non-use compared to partial-use of a tourniquet in bilateral total knee replacement: A Randomized- Control Trial This study aimed to compare the effects of non-use (NTU) and partial-use (before osteotomy to skin closure; BOO) of a tourniquet in bilateral total knee arthroplasty (TKA) on postoperative pain and complications.

详细描述

Despite numerous meta-analyses, and randomized-control trials (RCTs), there is still no conclusive evidence on the most effective, and efficient method of using a tourniquet.

There is gap of knowledge of method of tourniquet usage. Hence this study will provide the best method to apply tourniquet.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessor will not know whether which group are using tourniquet.

入排标准

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

入选标准

  • •patients with over 50 years of age and diagnosed with bilateral severe knee osteoarthritis undergoing bilateral TKA

排除标准

  • •patients having undergone previous knee surgery
  • •patients being subject to uncontrolled hypertension, coagulopathy, or recent knee sepsis
  • •patients with an ASA physical status grade > 2,
  • •inability to use patient-controlled analgesia (PCA), such as communication, or cognitive issues, or those patients who were allergic to medications used in the treatment process.

研究组 & 干预措施

Non-use of a tourniquet (NTU)

Experimental

No tourniquet is used throughout the surgery.

干预措施: None tourniquet (Procedure)

Partial-use of a tourniquet

Active Comparator

Partial use of a tourniquet is throughout the surgery.

干预措施: None tourniquet (Procedure)

结局指标

主要结局

Postoperative pain

时间窗: At postoperative Day1,2,3,4

Morphine consumption and Visual analog scale for pain minimum 0, maximum 10

次要结局

  • Blood loss(At postoperative Day1,2,3,4)

研究者

发起方
Queen Savang Vadhana Memorial Hospital, Thailand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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