NCT03393572已完成4 期
Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Rescue analgesia time
研究概览
简要总结
The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I and II
- •scheduled for laparoscopic hysterectomy
排除标准
- •ASA physical status more than II
- •Obesity (body mass index higher than 30 kg/ m2)
- •History of chronic opioids intake
- •Known hypomagnesaemia or hypermagnesaemia
- •Chronic alcoholism
- •Heart block
- •Renal failure
- •Patients with history of left ventricular failure
- •Patients taking beta-blocking drugs
- •Allergy to the study drugs
- •if surgery changed to open hysterectomy,
研究组 & 干预措施
Group BM
Active Comparator
bupivacaine 0.25% plus magnesium sulphate.
干预措施: Bupivacaine 0.25% (Drug)
Group BM
Active Comparator
bupivacaine 0.25% plus magnesium sulphate.
干预措施: Magnesium sulphate. (Drug)
Group BN
Active Comparator
bupivacaine 0.25% plus nalbuphine
干预措施: Bupivacaine 0.25% (Drug)
Group BN
Active Comparator
bupivacaine 0.25% plus nalbuphine
干预措施: nalbuphine (Drug)
结局指标
主要结局
Rescue analgesia time
时间窗: First 24 hours postoperatively
Time to first analgesia requirment(considering the extubation is the zero time)
次要结局
- Total analgesic consumption(First 24 hours postoperatively)
- Visual analogue scale [VAS](First 24 hours postoperatively)
研究者
Marwa Ahmed Khairy Elbeialy
Lecturer of Anesthesia
Ain Shams University
研究点 (1)
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