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临床试验/NCT03695640
NCT03695640Unknown4 期

The Effect of Magnesium Sulfate Added to Levobupivacaine in Continous Femoral Block on Analgesic Requirements Following Total Knee Arthroplasty

Ufuk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
60
试验地点
1
主要终点
Visual Analogue Score

研究概览

简要总结

This study is designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block following total knee arthroplasty.

详细描述

Pain after knee arthroplasty is a serious concern. This study was designed to investigate the effect of magnesium sulfate added to levobupivacaine in continuous femoral nerve block on analgesic requirements following total knee arthroplasty.

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 (Outcomes Assessor)

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

  • scheduled for elective unilateral primary total knee arthroplasty

排除标准

  • Patient refusal to enroll in the study
  • Patient refusal of neuraxial anesthesia
  • Existence of contraindications for neuraxial anesthesia
  • Known history of allergy to any of the study drugs

研究组 & 干预措施

Group L

Active Comparator

continuous femoral nerve block with levobupivacaine

干预措施: continuous femoral nerve block (Procedure)

Group LM

Experimental

continuous femoral nerve block with levobupivacaine and magnesium sulfate

干预措施: Magnesium Sulfate (Drug)

Group LM

Experimental

continuous femoral nerve block with levobupivacaine and magnesium sulfate

干预措施: continuous femoral nerve block (Procedure)

结局指标

主要结局

Visual Analogue Score

时间窗: T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours

measurement of postoperative pain using Visual Analogue Score. Minimum: 0 Maximum: 10. Higher values represent more pain, hence lower values are better

次要结局

  • Analgesic consumption(T0:(Baseline) Postoperative 1st hour, T1: Change in 2nd, T2: Change in 4th, T3: Change in 6th, T4: Change in 12th, T5: Change in 24th, T6: Change in 36th, T7: Change in 48th, T8: Change in 72nd hours)

研究者

发起方
Ufuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Baturay Kansu Kazbek

Principle Investigator

Ufuk University

研究点 (1)

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