Evaluation of Lidocaine Continuous Intravenous Administration for Postoperative Recovery After Colorectal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Readiness for discharge, checked twice a day
研究概览
简要总结
The purpose of this study is to check if lidocaine intravenous administration during surgery and 24 hours after surgery, associated with standardised management of the patient, helps to accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal neoplasms.
详细描述
One of the purposes of postoperative care is to shorten the duration of recovery, in order to reduce the complications and to improve the quality of life. After abdominal surgery, two factors can be modified: early mobilisation, thanks to optimal pain control, and return to a normal feeding, permitted by transit recovery. Opioids, which are usually used for pain control, delay the intestinal transit and can be responsible for side effects like drowsiness, nausea, urine retention.
Lidocaine is a local anaesthetic, which means that it can stop the pain if it is administrated around the nerves. It can also be used intravenously. In this way, it is supposed to decrease opioid consumption, accelerate intestinal transit and even decrease inflammation. Side effects of lidocaine appear at higher plasma concentrations than those considered in the study.
After randomisation, the patient will receive either intravenous lidocaine during the surgery and 24 hours after the surgery, or physiological serum (like placebo). Every patient will dispose of patient-controlled-analgesia with morphine and of a standardised care management. Data will be collected concerning pain level, morphine consumption, psychomotor performances, duration of ileus, speed of activity recovery, quality of recovery, and side effects. Biological evaluation of lidocaine concentration and inflammation will also be done.
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
- Single (Participant)
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
- •Colorectal neoplasm
- •Radical surgery
- •Median incision
排除标准
- •American Society of Anesthesiologists (ASA) score equal to or up to 3
- •Unwilling or unable to use patient-controlled analgesia (PCA)
- •Chronic consumption of opioids
- •Chronic drug or alcohol abuse
- •Chronic pain
- •Unable to read or write text
- •Inflammatory disease of intestinal tract
- •Allergy to morphine
- •Allergy to lidocaine
- •Severe atrioventricular conduction dysfunction without stimulator
- •Uncontrolled epilepsy
- •History of malign hyperthermia
- •Severe cardiac failure
- •Hepatic failure
- •Myasthenia
- •Treatment with beta blockers, antiarrhythmic calcium blockers, sultopride, nonselective monoamine oxidase inhibitor (MAOI)
- •Locoregional anaesthesia planned
- •Associated surgery concerning liver, pancreas, or gall bladder
- •Laparoscopic surgery
- •Severe psychiatric pathology
- •Refusal of the patient
结局指标
主要结局
Readiness for discharge, checked twice a day
次要结局
- Clinical side effects twice a day
- Pain every 4 hours the first day after surgery, then twice a day
- Morphine consumption: dose of titration, then twice a day
- Time of transit recovery
- Physical rehabilitation score daily
- Psychomotor test daily until reaching of preoperative values
- Quality of recovery score at 1st, 3rd, and 6th day
- Satisfaction score at discharge
- Biological inflammation the day before the surgery, then at 1st, 3rd, and 6th day
- Lidocaine concentration at the end of surgery and 24 hours forward