NCT04732364Unknown2 期
Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levo-bupivacine in Ultrasound Guided Erector Spinae Plan Block for Modified Radical Mastectomy
South Egypt Cancer Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- analgesia requirement
研究概览
简要总结
To compare the analgesic efficacy of dexmedetomidine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute and chronic pain management.
详细描述
3 groups.
Group (C) / (I):20 patient (control group) :
Patients will receive 20 ml 0.25% levobupivacaine into the interfascial plane below erector spinae muscle at level of T5.
Group (D)/ (II) :20 patient (Dexmetonidine group) :
Patient will receive 20ml 0.25% levobupivacaineas above + 1μ/kg dexmedetomidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female patient
- •American society of anesthesiologists (ASA) I and II physical status
- •age from 25 to 70 years old
- •scheduled for either left or right modified radical mastectomy (MRM).
排除标准
- •infection of the skin at or near site of needle puncture
- •coagulopathy
- •drug hypersensitivity or allergy to the studied drugs
- •central or peripheral neuropathy
- •significant organ dysfunction cardiac dysrrhythmias
- •obesity (BMI>35kg/m2)
- •recently use analgesic drugs
结局指标
主要结局
analgesia requirement
时间窗: 24 hours
first request for analgesia and total analgesia requirements
次要结局
- chronic pain assessment(6 months)
研究者
Peter Rafaat Edward Iskander
principal investigator
South Egypt Cancer Institute
研究点 (2)
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