Prospective, Randomized, Double Blind, Superiority Trial, Evaluating the Effect of Perioperative Lidocaine on Postoperative Opioid Consumption, Pain Ratings, Duration of Hospital Stay, Time to First Defecation, 30-day Mortality and Development of Chronic Pain in Patients Undergoing Video-assisted Thoracoscopic Procedures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Change in total morphine consumption (TMC)
研究概览
简要总结
Placebo-controlled study to analyze the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .
详细描述
Thoracoscopy (thoracic surgery) is a video-assisted minimally invasive operation in thoracic surgery, which is associated with pain after surgery. Trial drug Lidocaine is approved as pain medication. This placebo-controlled study analyzes the effect of perioperative intravenous lidocaine administration on total morphine consumption (TMC) and on pain intensity in thoracoscopic surgery .
Half of the patients will receive NaCl 0.9% (a saline solution without active ingredient) instead of Lidocaine.
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
- Double (Participant, Investigator)
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
- •Patients undergoing video-assisted thoracoscopic procedures under general anaesthesia.
- •American Society of Anesthesiologists (ASA) physical Status classes I to III
- •age ≥ 18 years
- •Patient informed consent
排除标准
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
- •Contraindications to self-administration of opioids
- •Women who are pregnant or breast feeding
- •Steroid therapy
- •Chronic pain therapy
- •Atrioventricular block grade II to III
- •Congestive heart failure
- •Liver insufficiency
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Lidocaine
perioperative IV administration regimen of lidocaine will be as follows: 1.5 mg/kg IV induction bolus dose (before intubation and at least 30 minutes before incision) followed by continuous infusion of 3.mg/kg/h, until 2 hours after skin closure
干预措施: Lidocaine (Drug)
Placebo
perioperative IV administration regimen of placebo solution (NaCl 0,9%) will be as follows: induction bolus (before intubation and at least 30 minutes before incision) followed by continuous infusion of placebo solution (NaCl 0,9%) until 2 hours after skin closure
干预措施: NaCl 0,9% (Drug)
结局指标
主要结局
Change in total morphine consumption (TMC)
时间窗: within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure
change in total morphine consumption (TMC) via Patient Controlled Analgesia (PCA)
change in pain intensity
时间窗: within the first 24 hours, measured at 1 hour, 2 hours, 4 hours, 8 hours, 16 hours, and 24 hours after skin closure
change in pain intensity of at least 1.5 units on the Visual Analogue Scale (VAS). The pain VAS is a unidimensional measure of pain intensity; the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 100 \[100-mm scale\])
次要结局
- Duration of hospital stay(from day of surgery until day of discharge from hospital (an average of 2 days))
- time to first defecation - Defined as the time from skin closure to the time of first defecation(From timepoint of surgical skin closure (end of surgery) to the timepoint of first defecation after surgical skin closure (an average of 2 days))
- Change in chronic pain(2 weeks, 3 months and 6 months after surgery)
- occurrence of nausea and/or vomiting(from the date of surgery until the date of discharge from hospital (an average of 2 days))