Effect of Perioperative Continuous Intravenous Infusion of Lidocaine on Postoperative Pain in Elderly Patients Undergoing Colorectal Cancer Surgery: a Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Pain scores of movement-evoked pain at postoperative 24 hours
研究概览
简要总结
Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group.
详细描述
Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group. In the lidocaine groups, 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. Blood samples will be collected from some patients in the lidocaine group for the measurement of lidocaine plasma concentration.In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 mL.
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)
盲法说明
Blinding of research personnel and patients will be maintained throughout the observation period. On the day of surgery, nurses who did not participate in the perioperative management will assign the standard configuration of the trial drugs, including intraoperative medication and the configuration of the postoperative analgesic pump, to the researchers before the induction of anesthesia. Throughout the study, the patients and researchers should not be unblinded until the statistical analysis of the study data is completed.
During the operation, an independent anesthesiologist will be responsible for the blood draw, and the postoperative blood samples will be collected together with the routine blood examination specimens. The investigators remained blinded throughout the observation period until the anesthesiologist or assessors observe significant adverse events of local general anesthesia toxicity.
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 alanine transaminase 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 third-degree 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 groups, 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. Blood samples will be collected from some patients in the lidocaine group for the measurement of lidocaine plasma concentration.
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 2 μg/kg, granisetron 12 mg 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
Pain scores of movement-evoked pain at postoperative 24 hours
时间窗: up to 24 hours postoperatively
The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, and 10 points representing the strongest pain.
次要结局
- Pain scores of movement-evoked pain at postoperative 48 and 72 hours(From the date of the end of surgery until the date of 72 hours postoperatively)
- Pain scores of pain at rest at 24, 48 and 72 hours postoperatively(From the date of the end of surgery until the date of 72 hours postoperatively)
- The incidence of moderate-to-severe movement-evoked pain at 24, 48 and 72 hours postoperatively(From the date of the end of surgery until the date of 72 hours postoperatively)
- The incidence of moderate-to-severe pain at rest at 24, 48, and 72 hours postoperatively(From the date of the end of surgery until the date of 72 hours postoperatively)
- The cumulative morphine consumption at 24, 48, and 72 hours postoperatively(From the date of the end of surgery until the date of 72 hours postoperatively)
- Time of Bowel function recovery(At 3 days after surgery)
- The incidence of postoperative nausea and vomiting during the first 72 hours postoperatively (any nausea or vomiting);(From the date of the end of surgery until the date of 72 hours postoperatively)
- The incidence of a composite of postoperative pulmonary complications during hospitalisation(during the period from the end of surgery to discharge, an average of 7 days)
- Length of hospital stay(during the period from the end of surgery to discharge, an average of 7 days)
- Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery(From the date of the end of surgery until the date of 72 hours postoperatively)
- Incidence of lidocaine toxicity(From the time of anesthesia induction until the date of 72 hours postoperatively)
- plasma lidocaine concentration(From the time of anesthesia induction until the date of 24hours postoperatively)
研究者
Chunling Jiang
Professor
West China Hospital