Intravenous Lidocaine in Carcinologic ENT Surgery: A Randomized Controlled Trial for Evaluation of Opioid Saving Strategy and Chronic Post-surgical Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Total morphine requirement during the first 48 postoperative hours
研究概览
简要总结
Lidocaine, local anesthetic used for more than five decades, is being intravenously administered aiming at managing pain in different types of surgeries with promising results. Opioid-induced hyperalgesia need to be considered in ear-nose-throat (ENT) surgery owing to the difficulty of locoregional anesthesia and high level of opioid consumption.
This randomized study aims to compare quality of perioperative analgesia after infusion of intravenous lidocaine during carcinological ENT surgery. The main purpose of this study is to evaluate morphine consumption during the 48 postoperative hours.
Others purposes are evaluation of peroperative remifentanil consumption, morphine consumption during the 24 postoperative hours, chronic post-surgical pain evaluated from 3 to 6 months after carcinologic ENT surgery, and incidence of side effects that can be attributed to lidocaine infusion.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing major carcinological ENT surgery (total laryngectomy, oropharyngectomy with or without mandibulotomy, crico-hyoido-epiglotto-pexy, intraoral extended resection, partial laryngectomy, partial pharyngectomy, extended pelvectomy, pelviglossectomy, with or without pectoralis major flap or free flap, with or without lymphadenectomy)
- •Patient receiving standardized Patient Controlled Analgesia (PCA)
- •Written informed consent
排除标准
- •Hypersensitivity to local anesthetics of the amide group,
- •Acute porphyria
- •Atrioventricular conduction disorders requiring permanent electro-systolic
- •Epilepsy not controlled by treatment
- •Hepatocellular insufficiency (PT<50%) or cirrhosis
- •Systolic heart failure (LVEF <50%)
- •Major inflation State
- •Hypersensitivity to any component of Glucose 5%
- •Treatment with beta-blockers or antiarrhythmic of Vaughan Williams classification
- •BMI > 30kg/m2
- •Patient already treated for chronic pain with level 3 analgesic or for neuropathic pain
- •Pregnant or lactating women
- •Refusal to give consent
- •Patient under legal protection measure
研究组 & 干预措施
Lidocaine 20mg/ml
Patients in Lidocaine group received an intravenous bolus injection of 1,5 mg/kg lidocaine (0,075mL/kg of Lidocaine 20mg/mL) followed by a continuous lidocaine infusion of 2 mg/kg/hr during surgery (0,1mL/kg/hr of Lidocaine 20mg/mL) and 1 mg/kg/hr in recovery room (0,05mL/kg/hr of Lidocaine 20mg/mL).
干预措施: Lidocaine 20mg/ml (Drug)
Glucose 5% (placebo)
Patients in control group received an intravenous bolus injection of 0,075mL/kg of placebo (Glucose 5%) by a continuous lidocaine infusion of 0,1mL/kg/hr of placebo (Glucose 5%) during surgery and 0,05mL/kg/hr of placebo (Glucose 5%) in recovery room.
干预措施: Glucose 5% (placebo) (Drug)
结局指标
主要结局
Total morphine requirement during the first 48 postoperative hours
时间窗: 48 postoperative hours (H48)
Standardized patient control analgesia (PCA) devices will be read at the 48th postoperative hour.
次要结局
- Total morphine requirement(24 postoperative hours (H24))
- Evaluation of chronic post-surgical pain(3 to 6 months after surgery (M3-6))
- Remifentanil peroperative consumption(At the end of surgery (an average of 3 hours et 10 minutes))
- Incidence of side effects that can be attributed to lidocaine infusion(3 to 6 months after surgery (M3-6))