跳至主要内容
临床试验/2024-518601-17-00
2024-518601-17-00招募中3 期

Phase III Randomized, Double-Blind Clinical Trial to Determine the Role of Magnesium Sulfate in Adductor Canal Block in Total Knee Arthroplasty

Fundacion Progreso Y Salud1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2024年10月14日最近更新:
相关药物

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
131
试验地点
1
主要终点
Time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia.

研究概览

简要总结

Evaluate the efficacy of perineural magnesium sulfate in prolonging analgesia when administered as an adjuvant to the local anesthetic ropivacaine in total knee arthroplasty.

入排标准

年龄范围
18 years 至 65+ years(18-64 Years, 65+ Years)
接受健康志愿者

入选标准

  • Patients scheduled for total knee arthroplasty due to gonarthrosis
  • ASA I, II, and III patients of both sexes.
  • Age between 18 and 80 years.
  • Informed consent signed, accepting participation in the study.

排除标准

  • Allergy or intolerance to local anesthetics, morphine or its derivatives, magnesium sulfate.
  • Patients with any condition that prevents the use of regional analgesia: anticoagulated, antiplatelet therapy, local or systemic infection.
  • Patients with difficulty understanding study-related information and collaborating in pain assessment.
  • Patients with major psychiatric pathology as per DSM-V.
  • Pregnancy and/or breastfeeding.
  • ASA IV Patients
  • Diabetes mellitus with the last glycated hemoglobin control greater than 7%.
  • Patients with neuromuscular diseases.
  • Morbid obesity.
  • Fibromyalgia
  • Myofascial pain syndrome.
  • Patients with prior treatment with corticosteroids or calcium antagonists in the last three months.
  • Patients with cardiovascular disease (congestive heart failure, severe valvular disease, symptomatic coronary artery disease, and/or congenital/anatomical heart abnormalities).
  • Patients with severe renal, hepatic, or respiratory disease.

结局指标

主要结局

Time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia.

Time in minutes elapsed from when the patient receives the adductor canal block until the first request for rescue analgesia.

次要结局

未报告次要终点

研究者

发起方
Fundacion Progreso Y Salud
申办方类型
Patient organisation/association
责任方
Principal Investigator
主要研究者

David Lineros Orozco

Scientific

Fundacion Progreso Y Salud

研究点 (1)

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