Lidocaine Infusion Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk: a Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,400
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS)
研究概览
简要总结
The goal of this clinical trial is to explore if perioperative lidocaine infusion decreases disease reoccurrence and metastasis risk in non-small cell lung cancer patients.
Participants will be randomly assigned (1:1) to the lidocaine or placebo group. The intervention initiates within 30 minutes before anesthesia induction with an intravenous loading dose of 1.5 mg/kg administered over 10-20 minutes. This is followed by a continuous maintenance infusion of 1.5-3 mg/kg/h (calculated as 1-1.5 mg/kg/h in protocol text, see note below) during surgery, terminating 1 hour after skin closure. Participants will be followed up for 36 months post-surgery. Blood samples will be collected at baseline, postoperative day 1, day 3, and upon discharge
详细描述
- Research design: This is a 1:1 parallel, double-blind (participants, investigators, and outcomes assessors) randomized controlled trial. Intravenous lidocaine or saline will be assigned to patients with lung cancer undergoing minimally invasive (thoracoscopic or robotic) surgery.
- Research Methods:
2.1. Intervention: 2% lidocaine hydrochloride or placebo (0.9% sodium chloride).
2.2. Dose planning: The intervention initiates within 30 minutes before anesthesia induction with an intravenous loading dose of 1.5 mg/kg (ideal body weight, IBW) administered over 10-20 minutes. This is followed by a continuous maintenance infusion of 1-1.5 mg/kg/h during surgery, terminating 1 hour after skin closure. The maximum infusion rate is capped at 120 mg/h. IBW is used to calculate dosage to prevent toxicity in overweight patients; however, for patients weighing less than their IBW, actual body weight is used. Patients in the placebo group receive the same volume and rate as the treatment group.
Dose Guidelines Based on IBW (Broca Index): Males: height (cm) - 100; Females: height (cm) - 105.
2.3. Dose adjustment: No dosage changes are permitted. If systemic local anesthetic toxicity is suspected, the infusion must be stopped immediately and not resumed. Supportive care and lipid emulsion therapy will be provided. If infusion is interrupted due to mechanical issues (e.g., pump malfunction), it may be restarted at the original rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
A random coding table is generated by statistical analysts, placed in a sealed and opaque envelope, and managed by an independent randomization specialist. The randomization specialist configures the medication according to the coding information, attaches the coding, and then provides it to the blinded anesthesiologist. Both patients, investigators and postoperative follow-up personnel are also blinded.
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 range: 18-80 years old.
- •Electively undergo minimally invasive (thoracoscopic or robotic) surgery for the treatment of lung cancer
- •Is willing and capable of providing consent.
排除标准
- •Palliative surgery without intention of cure.
- •Extensive comorbidities (ASA IV).
- •Patients with known or suspected allergy to lidocaine.
- •Patients who are currently pregnant or breastfeeding.
- •Patients who may experience adverse reactions due to accumulation of lidocaine during intravenous infusion, as stated in the Summary of Product Characteristics (SmPC) for lidocaine.
- •Currently, there is abnormal liver function, with ALT or AST levels exceeding the laboratory reference range by a factor of
- •Currently, there is severe renal insufficiency (serum creatinine ≥451umol/L or glomerular filtration rate (calculated using the MDRD formula) <30ml/min).
- •Patients with cardiac conduction abnormalities, including second-degree or third-degree heart block without a pacemaker, left bundle branch block, sick sinus syndrome, and pre-excitation syndrome (confirmed by medical history and electrocardiogram), as well as those with low cardiac output due to reduced left ventricular ejection fraction.
- •Concurrent use with continuous infusion of other local anesthetic drugs (such as epidural).
- •Patients who use drugs that may cause reasons for exclusion, including Class I and Class III antiarrhythmic drugs (such as mexiletine and amiodarone), cimetidine, and antiviral drugs. Eligibility will be determined by local clinicians and verified by clinical trial doctors.
- •Patients with body weight <40kg
研究组 & 干预措施
lidocine infusion group
Lidocaine is administered intravenously at an ideal body weight (IBW) of 1.5 mg/kg starting from anesthesia induction, for 10-20 minutes, and then continuously infused at 1-1.5 mg/kg/h until 1 hour after skin closure, with a maximum rate of 120 mg/h. Use ideal weight instead of actual weight to prevent toxicity in very overweight patients. In patients with a weight lower than the ideal weight, the actual weight should be used to calculate the dose.
干预措施: Lidocaine (drug) (Drug)
normal saline group
The normal saline is administered at the volume calculated based on the equivalent volume of lidocaine dose according to body weight
干预措施: Lidocaine (drug) (Drug)
结局指标
主要结局
Disease-Free Survival (DFS)
时间窗: Up to 36 months after operation
DFS is defined as the time from the date of surgery to the first documentation of disease recurrence (including local recurrence, regional lymph node metastasis, or distant metastasis) or death from any cause.
次要结局
- Overall Survival (OS)(36month after operation)
- EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)(Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery)
- Cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy - Lung (FACT-L)(Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery)
研究者
Changshun Huang, MD
Departmental director
First Affiliated Hospital of Ningbo University