Effect of Perioperative Continuous Intravenous Infusion of Lidocaine on Postoperative Pain and Long-term Survival in Elderly Patients Undergoing Colorectal Cancer Surgery: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 276
- 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 NCT05920980 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 colorectal cancer surgery.
详细描述
This study is a further observation and follow-up of the patients enrolled in the registration number NCT05920980 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 colorectal cancer surgery. Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group. In the lidocaine group, lidocaine 1.5mg/kg/h was continuously infused (using ideal body weight) during the whole procedure. Postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg) diluted to 200ml with saline until 72h after surgery. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2μg/kg, granisetron 12mg diluted to 200mL in 0.9% normal saline solution with a total volume of 200mL.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
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were at least 60 years old;
- •American Society of Anesthesiologists (ASA) physical status I to III;
- •Body-mass index of 18-30 kg/m2;
- •Scheduled for elective colorectal surgery.
排除标准
- •Metastases occurring in other distant organs;
- •Severe hepatic insufficiency (aspartate aminotransferase or alaninetransaminase or bilirubin >2.5 times the upper limit of normal);
- •Renal impairment (creatinine clearance <60 mL/min);
- •Cardiac rhythm disorders or systolic heart failure (second-and thirddegree heart block, ejection fraction <50%);
- •Allergies to any of the trial drugs; chronic opioid use;
- •Inability to comprehend numeric rating scale.
研究组 & 干预措施
Lidocaine group
Patients in the lidocaine group, lidocaine 1.5mg/kg/h is continuously infused (using ideal body weight) during the whole procedure, postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg) diluted to 200ml with saline until 72h after surgery.
干预措施: lidocaine (Drug)
Placebo group
In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2μg/kg, granisetron 12mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 mL.
干预措施: Placebo (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.
次要结局
- Disability-free surviva survival(6 months, 1 year, 3 years, 5 years postoperatively)
- The prevalence of neuropathic pain(3 months, 6 months, 1 year, 3 years, 5 years postoperatively)
- Overall survival after surgery(6 months, 1 year, 3 years, 5 years postoperatively)
- Brief Pain Inventory(BPI) pain interference subscale score(3 months, 6 months, 1 year, 3 years, 5 years postoperatively)
- The incidence of chronic pain at 6 months ,1 year, 3 years and 5 years postoperatively(6 months, 1 year and 3 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