Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection: A Prospective, Randomized, Four-arm, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
Lidocaine and ketamine both are being used for perioperative analgesia. Perioperative lidocaine infusion has been shown to reduce postoperative pain and opioid consumption. Perioperative low dose Ketamine has shown improved postoperative pain and reduced opioid usage. We therefore tested the hypothesis that the combination would provide better analgesia in the milieu of intrathecal morphine.
详细描述
All study participants were monitored according to American Society of Anesthesiologists guidelines. All received intrathecal morphine (300 to 400 mcg) at L3-4 interspace via 25 G Whitacre needle. Participants were then randomized (computer generated) into one of four groups.
General anesthesia was induced and endotracheal intubation was done. Immediately, after intubation, Lidocaine group (L) received a Lidocaine infusion at 0.33 mg/kg/h.
The Ketamine group (K) received a ketamine infusion at 70 mcg/Kg/h. The Lidocaine-Ketamine group (LK) received a Lidocaine infusion at 0.33 mg/kg/h plus a Ketamine infusion at 70 mcg/Kg/h.
The control group (P) received a normal saline infusion to keep the blind. The infusions were stopped approximately 30-45 minute before the completion of surgery.
All participants received a hydromorphone patient-controlled analgesia (PCA) via a pump. All were given acetaminophen 650 mg every 6 hrs for 4 days.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All persons are blinded as the drug is formulated by the investigator who is not the care giver or outcomes assessor
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 2-4
- •Elective major liver resection
- •Signed informed consent
排除标准
- •ICU admission after surgery
- •tracheal extubation not planned after surgery
- •language barrier
- •mental impairment
- •severe coagulopathy
- •chronic pain or opioid dependance or both
- •alcohol/substance abuse
- •allergy to the study drugs
- •refusal for spinal
- •infection at site of spinal
研究组 & 干预措施
Lidocaine
This group will receive lidocaine infusion perioperatively
干预措施: Lidocaine (Drug)
Ketamine
This group will receive ketamine infusion perioperatively
干预措施: Ketamine (Drug)
Lidocaine+ketamine
This group will receive a combination of lidocaine and ketamine infusion, perioperatively
干预措施: Lidocaine+ketamine (Drug)
placebo
This group will receive saline infusion as placebo perioperatively
干预措施: Saline (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 24 hr
Total milligrams of opioids consumed would be measured
次要结局
- Chronic pain(12 weeks)
- Patient satisfaction(72 hrs)
- Opioid consumption(72 hrs)
- Opioid related side effects(72 hrs)
研究者
Shalini Dhir
Associate Professor
Lawson Health Research Institute