Effect of Prolonging Intravenous Lidocaine on Chronic Pain and Long-term Quality of Life in Patients Undergoing Hepatectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- The incidence of chronic pain at 3 months postoperatively
研究概览
简要总结
This study is a further observation and follow-up of the patients enrolled in the registration number NCT04295330 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing liver cancer surgery.
详细描述
This study is a further observation and follow-up of the patients enrolled in the registration number NCT04295330 to further evaluate the effect of long-term infusion of lidocaine on postoperative chronic pain, long-term quality of life and survival rate in patients undergoing liver cancer surgery. 272 patients with primary liver cancer who meet the inclusion criteria are included. According to the random number, the patients are divided into lidocaine group and conventional analgesia group.In the lidocaine group, a bolus injection of lidocaine 1.5 mg/kg, given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine , sufentanil , granisetron diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline instead of lidocaine will be administered. Blood samples will be drawn immediately after the bolus infusion of lidocaine, at the end of surgery, and 24 hours after surgery to measure plasma lidocaine concentrations. Blood samples will also be collected at 24 hours after surgery for subsequent measurement of inflammatory factors. Numeric rating scale(NRS) is used to evaluate pain at rest and light activities at postoperative 24, 48, 72 hours. The recovery time of postoperative gastrointestinal function, length of hospital stay, and the incidence of lidocaine toxicity within postoperative 72 hours will be recorded. Follow-up after discharge includes chronic pain, the impact of chronic pain on quality of life, the relapse-free survival and overall survival from postoperative 3 months to 5 years.
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)
盲法说明
The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.
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
- •Age: 18-80 years old American Society of Anesthesiologists(ASA) Ⅰ～III BMI≤30 Primary single hepatocellular carcinoma resection was proposed for patients undergoing laparotomy (median incision, right subcostal incision/inverted L-shaped incision)
排除标准
- •Primary liver cancer with malignant tumors of other organs (such as lung, kidney, intestine, etc.).
- •Primary hepatocellular carcinoma with portal vein or inferior vena cava and other large vascular thrombus.
- •Long-term opioid use, alcohol or drug abuse or any of the drugs (lidocaine, etc.) used in this study were contraindicated and allergic for patients.
- •Patients with severe hepatic and renal dysfunction (total bilirubin >1.46mg/dl, glomerular filtration rate <30ml/min /1.73㎡ or end-stage renal disease).
- •Severe heart disease (severe heart block (including sinoatrial, atrioventricular, and intraventricular block); Severe heart failure (ejection fraction <20%); Sinus bradycardia; Patients with Adams-Stokes syndrome, preexcitation syndrome, etc Patients with a history of uncontrolled seizures or acute porphyria. Long-term use of cimetidine and β-blockers (lidocaine metabolism is inhibited through the liver, resulting in increased blood concentration of the drug, which can lead to adverse cardiac and nervous system reactions).
- •Patients treated with drugs that are contraindicated with lidocaine (phenobarbital, thiopental, sodium nitroprusside, mannitol, amphotericin B, ampicillin, mesonotal, sulfadiazine sodium); Patients who are using enoxacin, lomefloxacin, norfloxacin, and prulifloxacin.
- •Patients with a history of gastrointestinal bleeding or perforation after nsaids;Patients with active gastrointestinal ulcers/bleeding or who have had recurrent ulcers/bleeding in the past.
- •Patients who had taken other experimental drugs or were participating or participating in other clinical trials within 3 months of enrollment.
- •Failure to cooperate with the study for any reason or the researcher considers it inappropriate to be included in the study.
研究组 & 干预措施
Lidocaine group
General anesthesia is induced in the lidocaine group with intravenous lidocaine 1.5mg/kg for ten minutes, followed by continuous injection of lidocaine 1.5mg/kg.h. At the end of the operation, the patient controlled intravenous analgesia with lidocaine is used, and the dose of lidocaine is 30mg/kg(no more than 2000mg at most).
干预措施: Lidocaine Hydrochloride, Injectable (Drug)
Conventional analgesia group
The lidocaine is replaced by identical volumes and rates of 0.9% saline. At the end of the operation, the patient controlled intravenous analgesia without lidocaine is used.
干预措施: 0.9% normal saline (Drug)
结局指标
主要结局
The incidence of chronic pain at 3 months postoperatively
时间窗: 3 months postoperatively
Chronic pain is defined as pain that lasts or recurs for longer than 3 months. For chronic postsurgical pain(CPSP), it mainly refers to the pain that persists past normal healing time. Pain scoring is performed at 3 months using the Numerical Rating Scale(NRS), with 11 digits ranging from 0 to 10 indicating the degree of pain,0 indicating no pain, and 10 indicating severe pain. Subjects choose a number to indicate the degree of pain based on their personal pain experience. The impact of chronic pain on the quality of life is also assessed by Brief Pain Inventory score.
次要结局
- The incidence of chronic pain at 6 months ,1 year,3 year and 5 year postoperatively(6 months, 1 year and 3 year postoperatively)
- The levels of inflammatory factors at 24 hours after surgery(24 hours postoperatively)
- The incidence of moderate to severe pain at 24, 48 and 72 hours after surgery at rest and during movement;(At 3 days after surgery)
- The cumulative morphine consumption at 24, 48 and 72 hours postoperatively(At the end of the surgery，24，48 and 72 hours after surgery)
- The incidence of a composite of postoperative pulmonary complications during(during the period from the end of surgery to discharge)
- Length of hospital stay(during the period from the end of surgery to discharge)
- Plasma lidocaine concentration immediately after loading，after surgery and 24-hours postoperatively(Immediately after bolus, after surgery and 24-hour postoperatively)
- The incidence of lidocaine toxicity within 72 hours after operation(within 72 hours after operation)
- Overall survival after surgery(6 months, 1 year, 3 years, 5 years postoperatively)
- Disability-free surviva survival(6 months, 1 year, 3 years, 5 years postoperatively)
- Recurrence-free survival after surgery(6 months, 1 year, 3 years, 5 years postoperatively)
研究者
Chunling Jiang
Professor
West China Hospital