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临床试验/NCT06520475
NCT06520475已完成3 期

Efficacy of Bupivacaine-magnesium Combination Versus Bupivacaine Alone in Genicular Nerve Block in Total Knee Replacement Surgeries: a Randomized Controlled Study

Cairo University1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
94
试验地点
1
主要终点
Numerical Rating Scale

研究概览

简要总结

It is proved that the addition of magnesium sulfate to local anesthetics for neuraxial anesthesia improves the quality of analgesia and prolongs the duration of anesthesia . In-vitro and in-vivo studies have demonstrated that magnesium enhances the local anesthetics effect on peripheral nerves .

No previous studies were conducted on magnesium sulfate as an adjuvant to the local anesthetic in genicular nerve block. Hence, this study will be conducted to assess analgesic efficacy of magnesium sulfate when added to bupivacaine in ultrasound guided genicular nerve block

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist (ASA) I or II physical status.
  • Between 18 and 70 years of age.
  • Both genders.
  • Patients undergoing total knee replacement surgery.

排除标准

  • Patient refusal.
  • ASA Ⅲ and Ⅳ patients.
  • Known allergy to the study drugs.
  • Hypermagnesemia.
  • Central or peripheral neurological disease.
  • Pregnancy.
  • Drug or alcohol abuse.
  • Localized infection at the site of the block.
  • Bleeding disorder (platelets count less than 100,000 or international normalized ratio more than 1.4)

结局指标

主要结局

Numerical Rating Scale

时间窗: 24 hours post-operatively

Pain will be assessed with Numerical Rating Scale. Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible.

次要结局

  • Patient satisfaction(24 hours post-operatively)
  • First request for analgesia(24 hours post-operatively)
  • Total opioid consumption(24 hours post-operatively)

研究者

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

AbdElKhalik Mahmoud Shaban

Lecturer of anaesthesia

Cairo University

研究点 (1)

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