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临床试验/NCT05144425
NCT05144425Unknown不适用

Evaluation of Blood Loss and Pain in TKA With and Without Pneumatic Tourniquet, A Randomized Controlled Trial

Assiut University0 个研究点目标入组 100 人开始时间: 2021年12月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
amount of perioperative blood loss in ml with and without using tourniquet during TKA

研究概览

简要总结

The aim of our study is to determine whether the use of a tourniquet during TKA would affect total measured blood loss , operation time, postoperative complications; hemoglobin concentration; limb swelling and postoperative pain.

详细描述

Tourniquets are widely used in total knee arthroplasty (TKA) . TKA has been reported to be associated with significant blood loss which at times necessitates transfusion. Although the tourniquet is widely used by orthopedic surgeons, its role is controversial . Several studies have shown that using a tourniquet in TKA could reduce the total blood loss, while results from others indicated the opposite . Therefore the relationship between the use of a tourniquet and the total blood loss of patients undergoing TKA is still unclear. The use of a tourniquet is believed to be effective for decreasing intraoperative blood loss and creating a bloodless surgical field, which theoretically would facilitate the cementing technique and other surgical procedures. However, reactive blood flow reaches its peak within five minutes after the tourniquet has been released Complications reported as a consequence of tourniquet application are skin injury [skin abrasions, blisters, breaks , pressure necrosis], nerve injury, post tourniquet syndrome, Deep venous thrombosis, Postoperative pain, wound healing disorders and early infections

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
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any patient with knee osteoarthritis undergoing primary total knee arthroplasty

排除标准

  • patients with hemorrhagic disease
  • patient with revision total knee arthroplasty
  • patient with history of vascular thrombosis
  • patients taking anti-platelet agents due to cardiovascular disease
  • patients with hemoglobin level below 10gm/dl

结局指标

主要结局

amount of perioperative blood loss in ml with and without using tourniquet during TKA

时间窗: 48hr

Total measured blood loss will be calculated as the volume of the intraoperative blood loss plus the volume of postoperative visible blood loss from the hemovac drains and will be expressed as mL

次要结局

  • post operative pain measured on VAS after TKA with and without using tourniquet(48hr)
  • operative time in minutes with and without using tourniquet in TKA(operation time)
  • hemoglobin level in gm/dl preoperative and postoperative(48hrs)

研究者

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

mohamed elbasel abd-elraheem

Assiut medical school ethical review board [assiut]

Assiut University

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