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临床试验/NCT06445829
NCT06445829尚未招募不适用

Magnesium Sulfate Combined With Intraarticular Cocktail Injection for Analgesia After Simultaneous Bilateral Total Knee Arthroplasty

Chang Gung Memorial Hospital0 个研究点目标入组 80 人开始时间: 2024年6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
尚未招募
发起方
入组人数
80
主要终点
VAS score

研究概览

简要总结

Total knee arthroplasty is a safe procedure with excellent outcome. In recent years, simultaneous bilateral total knee arthroplasty has become more popular. In views of enhanced recovery after surgery, intraarticular cocktail injection for pain control has been developed. However, the safety accumulation dose for simultaneous bilateral knee injection is still an issue. Recently, adding magnesium sulfate to intraarticular cocktail injection in unilateral total knee arthroplasty has been proved effective for prolong pain control. We tempt to conduct a double blinded study to evaluate that whether adding magnesium sulfate intraarticular cocktail injection to one of the knees in simultaneous bilateral total knee arthroplasty patient could effectively decrease pain score with less analgesia dose or not.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • bilateral knee advanced osteoarthritis or osteonecrosis who tend to receive simultaneous bilateral total knee arthroplasty

排除标准

  • hypersensitivity to magnesium sulfate
  • hypermagnesemia
  • severe cardiac, hepatic or renal compromised

研究组 & 干预措施

Cocktail injection with Magnesium Sulfate

Experimental

Cocktail injection with Marcaine, Dexamethasone, normal saline and Magnesium Sulfate

干预措施: Magnesium sulfate (Drug)

结局指标

主要结局

VAS score

时间窗: day 0, day 1, day 2, day 3, day 7

muscle power

时间窗: day 0, day 1, day 2, day 3

Straight leg raised test

时间窗: day 0, day 1, day 2, day 3

active range of motion

时间窗: day 0, day 1, day 2, day 3

次要结局

  • Magnesium level in blood(day 0, day 1)
  • Calcium level in blood(day 0, day 1)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

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