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临床试验/NCT02930707
NCT02930707Unknown2 期

Efficacy and Safety of Magnesium Sulfate Added to Local Anesthetic in TAP Block for Postoperative Analgesia Following Total Abdominal Hysterectomy.

Assiut University0 个研究点目标入组 60 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
60
主要终点
total postoperative morphine consumption

研究概览

简要总结

Major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. This increases the incidence of post-operative morbidity.

The objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in patients undergoing total abdominal hysterectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • weight: 50- 85 kg.
  • ASA score: I-III
  • scheduled for total abdominal hysterectomy

排除标准

  • history of relevant drug allergy.
  • coagulation disorders.
  • opioid dependence.
  • psychiatric illnesses that would interfere with perception and assessment of pain.

研究组 & 干预措施

Magnesium group

Active Comparator

patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulphate 10% (200 mg), on each side of the abdominal wall.

干预措施: Magnesium Sulfate (Drug)

control group

Placebo Comparator

patients received ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

total postoperative morphine consumption

时间窗: postoperative 24 hours

total amount of rescue morphine consumption in the first 24 hours postoperatively

次要结局

  • postoperative pain(postoperative 24 hours)
  • first request of rescue analgesia(postoperative 24 hours)
  • side effects(postoperative 24 hours)

研究者

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

Ahmad Mohammad Abd El-Rahman

lecturer of anesthesia,ICU, and pain management

Assiut University

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