a Pilot Randomized Controlled Trial on the Safety and Efficacy of Different Doses of Lidocaine Infusion for Postoperative Analgesia in Elderly Patients With Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- The incidence of moderate to severe pain (NRS score≥4）during movement (i.e.deep breathing) 24 hours after surgery
研究概览
简要总结
patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery
详细描述
patients who meet the enrollment criteria will be randomized 1:1:1:1 to the different doses of lidocaine or the placebo group. In the lidocaine groups, at the beginning of surgery, lidocaine 0.5mg/kg, 1.0mg/kg, and 1.5mg/kg per hour were continuously infused (using ideal body weight) respectively during the whole procedure. In contrast, the control group was infused with the same dose of normal saline. All the infusion procedures will be stopped at the end of surgery. Subsequently, all subjects will receive an analgesic device named Patient-Controlled Intravenous Analgesia pump, briefly, PCIA pump during the first 72 postoperative hours. PCIA pump contains lidocaine 30mg/kg, sufentanil 2 μg/kg, and granisetron 12 mg diluted to 200 mL in 0.9 % normal saline, while in the placebo group, the lidocaine will be replaced with the equal dose of 0.9% normal saline and other components unchanged. All the background infusions of PCIA will be set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.
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)
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
- •Age over 60 years old；
- •American Society Anesthesiologygist(ASA)I~III；
- •Patients scheduled for colorectal cancer surgery；
- •The surgery takes more than two hours
排除标准
- •BMI≥30kg/㎡or BMI≤18kg/㎡；
- •Combined with other organ malignancies；
- •Chronic opioid use, substance abuse, contraindication to the use or incompatibility of any drug in the study；
- •Patients with liver and kidney insufficiency and chronic pain at the surgical site；
- •Accompanied by severe heart disease (such as severe atrioventricular block, severe heart failure, etc.)；
- •A history of uncontrolled seizures or acute porphyria；
- •Patients who have taken other experimental drugs or participated in or are participating in other clinical trials within 3 months before being enrolled in the study
研究组 & 干预措施
IVL0.5 group
At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.
干预措施: Lidocaine Hydrochloride 2% Injection Solution (Drug)
IVL1.0 group
At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.
干预措施: Lidocaine Hydrochloride 2% Injection Solution (Drug)
IVL1.5 group
At the beginning of surgery, lidocaine 0.5mg/kg per hour will be continuously infused (using ideal body weight) and stopped at the end of the procedure.
干预措施: Lidocaine Hydrochloride 2% Injection Solution (Drug)
Placebo group
At the beginning of surgery, in the placebo group, the same dose of normal saline as the experimental groups will be given until the procedure is over.
干预措施: 0.9% NaCl (Drug)
结局指标
主要结局
The incidence of moderate to severe pain (NRS score≥4）during movement (i.e.deep breathing) 24 hours after surgery
时间窗: The first 24 hours after surgery
The pain is evaluated using a numbering rating score(NRS).NRS scores range from 0 to 10 points, with 0 points repressing no pain,1-3points repressing mild pain, 4-6 points repressing moderate pain, 7-9 points repressing severe pain, and 10 points repressing the strongest pain.
次要结局
- The blood concentration of lidocaine immediately and 24 hours after the operation(immediately after the operation; 24 hours after the operation)
- The incidence of moderate to severe pain 24 hours after surgery at rest, 48 and 72 hours after surgery, both at rest and during movement(24 hours after surgery at rest; 48 and 72 hours after surgery, both at rest and during movement)
- Incidence of lidocaine toxicity within 72 hours after surgery(within 72 hours after surgery)
- Incidence of adverse reactions to opioids within three days after surgery(within three days after surgery)
- The incidence of a composite of postoperative pulmonary complications during hospitalization(from the end of surgery to discharge, up to 1 week)
- Quality of Recovery Scale Score (QoR-15) at 24, 48, and 72 hours after surgery(24, 48, and 72 hours after surgery)
- Length of hospital stay(from the end of surgery to discharge, up to 1 month.)
- Bowel function recovery(From the end of surgery to discharge, up to 1 week)
研究者
Chunling Jiang
Professor
West China Hospital