Intravenous Lidocaine for Perioperative and Postoperative Analgesia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- Reduction of opiods used during perioperative period and other analgesics used during postoperative period
研究概览
简要总结
Postoperative pain continues to be untreated despite the application of multimodal analgesia, medication and new analgesic techniques. Traditional opioid pain treatment has many side effects, while invasive methods, such as epidural catheter, have high costs and difficulties during application.
Lidocaine is a local anesthetic and its administration with intravenous routes has analgesic, antihyperalgic and antiinflammatory action. It increases the motility of the intestine and has antiemetic properties. The advantage of this method is the low cost of the preparation and its easy application. The intravenous administration of lidocaine for postoperative analgesia is recently used and not sufficiently researched technique .
详细描述
The purpose of this research is to investigate the analgesic effects of intravenous lidocaine in the perioperative and postoperative period, on various surgical interventions. In the perioperative period, its effect on the reduction of opiodic use will be evaluated, while during the postoperative period will be evaluate the degree of analgesia, the rate of reduction of additional analgesics, the impact on the clinical parameters and the patient's rehabilitation.
The research will be conducted at the Clinic of Gynecology and Obstetrics, the Surgery Clinic, the Urology Clinic, the Orthopedic Clinic, of Universitary Clinical Centre of Kosovo and the American Hospital in Pristina, Republic of Kosovo.
The study will be conducted during the period April 2018 - January 2020.
After obtaining a permit from the ethics committee, all patients to be investigated will be informed first through the information form for all the risks and advantages of this analgesic technique and from them will be consented to their participation in the research.
In the intervention group of the study will be included 520 patients of both genders and ages 18-65 years. Patients will undergo these surgical interventions: gynecological, abdominal, laparoscopical, urological and orthopedic interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of both genders from 18 to 75 years
- •ASA physiological status I-III
- •Participation in abdominal, orthopedic, laparoscopical, gynecological and urological interventions.
排除标准
- •Patient rejection
- •History of chronic opioid intake
- •History of renal, hepatic or psychiatric disorders
- •Heart failure,
- •Organ transplant history,
- •Lidocaine allergy
- •Family history of malignant hyperthermia
研究组 & 干预措施
Group I
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
干预措施: Lidocaine Hydrochloride (Drug)
Group II
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation
干预措施: Lidocaine Hydrochloride (Drug)
Group II
at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation
干预措施: Lidocaine Hydrochloride and Ketamine (Drug)
The control group
will be given opioids during surgery, opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction of opiods used during perioperative period and other analgesics used during postoperative period
时间窗: 48 hours after surgical intervention
The primary outcome measures are: the use of opiods and other analgesics during and 48 hours after the surgical intervention. During the intraoperative period, it will be investigated how the application of intravenous lidocaine will reduce the amount of opiodes used, amd during the postoperative period will be investigated when the application of other analgesics will start and which analgesics will be used as well,how often they will be given and in which dose. The analgesics which will be investigated include routine analgesics found in our hospital: * tramadol * acetaminophen * diclophenac * ketorolac * others
次要结局
- Pain scores measured at rest and during the movement with Visual Analog Scale(48 hours after surgical intervention)
研究者
Rajmonda Nallbani-Komoni
Principal investigator
University Clinical Centre of Kosova