Intravenous Lidocaine for Postoperative Recovery in Liver Surgery, a Randomized Double Blinded Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Opioid consumption at 24 hours
研究概览
简要总结
This is a randomized double blinded placebo-controlled study, conducted in Lund, Sweden. Patients will be randomized in two groups, with a ratio of 1:1. The experimental arm will receive intravenous Lidocaine perioperatively, and the Control arm will receive placebo, i.e. normal Saline. Postoperative both arms will get routine pain Control with PCA, Patient Controlled Analgesia with an intravenous Oxycodone-infusion. Outcome-measures will include patients pain intensity scoring, and opioid consumption.
详细描述
Patientes will be randozied in blocks of eight.
The experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. The placebo arm will receive the same amount of normal Saline instead. Pain intensity scoring, measured by Numerical Rating Scale, NRS, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 yy
- •Patient planned for minor hepatectomy
- •Signed informed consent
排除标准
- •Pregnancy
- •Elevated liver enzymes
- •AV-block >1, without pacemaker
- •WHO class >2
- •Allergy against Lidocain or other amid-type local anasthesia
- •Heart failure
- •Treatment with class III anti-arythimic medication
- •Preoperative ongoing opioid usage
- •Use of : Erythromycin, clarithromycin, Fluvoxamine, Cimetidine, ciprofloxacin, antivirala-HIV-läkemedel or imidazol the week before surgery.
研究组 & 干预措施
Lidocaine arm
The experimental arm will receive a bolus of 1,5mg/kg Lidocaine before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery.
干预措施: Lidocaine (Drug)
Placebo arm
The placebo arm will receive the same amount of normal Saline.
干预措施: Normal saline (Drug)
结局指标
主要结局
Opioid consumption at 24 hours
时间窗: 24 hours postoperatively
Sum of opioids consumed
次要结局
- Opioid consumption at 48 hours(48 hours postoperatively)
- Opioid consumption at 72 hours(72 hours postoperatively)
- Opioid consumption at 96 hours(96 hours postoperatively)
- Postoperative pain intensity(Day 0-5 postoperatively, twice every day)
- Time to return of Bowel function(Day 0-30 postoperatively)
- Number of participants with Postoperative nausea and vomiting(Day 1-5 postopertively)
- Level of Postoperative nausea and vomiting(Day 1-5 postopertively)
- Days in hospital(0-90 days postoperatively)
- Level of MEGX concentrations(Twice during surgery, and once 1 hour after surgery.)
- Level of Lidocaine concentration(Twice during surgery, and once 1 hour after surgery.)
- Mortality(30 days postoperatively)
- Rating of Quality of recovery-40(Day 1-5 postoperatively)
- Number of participant with Adverse Events(0-30 days)
- Opioid consumption at 120 hours(120 hours postoperatively)
- Number of participants with Postoperative comlications(30 days postoperatively)
- Level of Postoperative comlications(30 days postoperatively)
- Level of adverse events(0-30 days)
- Number of participants with Chronic Postsurgical pain(3 months after surgery)
- Level of Chronic Postsurgical pain(3 months after surgery)