Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to first analgesia
研究概览
简要总结
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy
详细描述
Several adjuvants have been added to them to enhance the effects of those blocks. Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are some of them. results are variable.
Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also considered to influence voltage sensitive Calcium ions channels, opioid receptors, and monoaminergic receptors. Therefore, it is considered overall to affect nociception.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •Both sexes.
- •ASA (American Society of Anesthesiology) physical status II-III.
- •Scheduled for open thoracotomy.
排除标准
- •Contraindications to or failed paravertebral block .
- •Body mass index (BMI) >35 kg/m
- •The likelihood of postoperative mechanical ventilation.
- •Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol, or recreational drug addiction.
- •Hypersensitivity to ketamine or levobupivacaine.
研究组 & 干预措施
Ketamine Group
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)).
干预措施: Ketamine + Levobupivacaine (Drug)
Control Group
patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline)
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Time to first analgesia
时间窗: 24 hour postoperatively
The time till the first rescue of analgesia of morphine. Patients can receive incremental doses of morphine 3 mg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is \> 3.
次要结局
- Total amount of morphine consumption(24 hour postoperatively)
- Pain intensity during rest(48 hour postoperatively)
- Pain intensity during deep breathing(48 hour postoperatively)
- Incidence of chronic pain(three months postoperatively)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Tanta University
Tanta University