Efficacy and Safety of Ketamine Versus Magnesium Sulphate as Adjuvants to Levobupivacaine in Ultrasound (US) Bi-level Erector Spinae Block in Breast Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- total morphine consumption in first 48 hours
研究概览
简要总结
Our aim will be to compare the analgesic efficacy and safety of ketamine and magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy.
详细描述
The participating females will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into one of 3 groups.
Group (C) / (I): 20 patients (control group):
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and T7.
Group (K) / (II): 20 patients (Ketamine group):
Patient will receive 20ml 0.25% levobupivacaine as above + 2 mg /kg ketamine.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age of 18 - 60 years.
- •ASA grade I - II.
排除标准
- •Patient refusal. known allergy to the study drugs skin infection at site of needle puncture significant organ dysfunction Coagulopathy drug or alcohol abuse psychiatric illness that would interfere with perception and assessment of pain.
研究组 & 干预措施
Group (K) (Ketamine group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg ketamine at each level with total dose 2mg/kg
干预措施: Ketamine (Drug)
Group (C) (control group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7.
干预措施: Ultrasound (US) bi-level erector spinae block (Procedure)
Group (C) (control group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7.
干预措施: levobupivacaine (Drug)
Group (K) (Ketamine group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg ketamine at each level with total dose 2mg/kg
干预措施: Ultrasound (US) bi-level erector spinae block (Procedure)
Group (K) (Ketamine group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg ketamine at each level with total dose 2mg/kg
干预措施: levobupivacaine (Drug)
Group (M) (magnesium sulphate group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg MgSo4 at each level with total dose 2mg/kg
干预措施: Ultrasound (US) bi-level erector spinae block (Procedure)
Group (M) (magnesium sulphate group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg MgSo4 at each level with total dose 2mg/kg
干预措施: levobupivacaine (Drug)
Group (M) (magnesium sulphate group)
Patient will receive 10 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5 and 10 ml at level of T7+ 1 mg / kg MgSo4 at each level with total dose 2mg/kg
干预措施: Magnesium Sulfate (Drug)
结局指标
主要结局
total morphine consumption in first 48 hours
时间窗: 48 hours
determine the analgesic effect of ketamine and magnesium sulphate in decreasing morphine consumption
time to first request of analgesia
时间窗: 48 hours
次要结局
未报告次要终点
研究者
Ali Rabiee Ali
Principal Investigator
Assiut University