Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Postoperative opioid consumption
研究概览
简要总结
The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy
详细描述
Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct.
Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •ASA physical status I-II
- •Age ≥ 18 years old
排除标准
- •Allergy in local anesthetics
- •History of liver, kidney or heart failure
- •Existence of chronic pain history or daily analgesics
- •Psychiatric disorders
- •Inability to understand pain assessment
研究组 & 干预措施
Lidocaine
Intraoperative administration of lidocaine to patients undergo laparoscopic cholecystectomy.
Prior induction to anesthesia, lidocaine bolus 1.5 mg / kg will be administered to the lidocaine group and then patients will be connected to a continuous 2 mg / kg / h administration of lidocaine until the end of the procedure.
干预措施: Lidocaine (Drug)
Placebo
Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy.
干预措施: Placebo (Drug)
结局指标
主要结局
Postoperative opioid consumption
时间窗: 24 hours after the procedure
The total dose of tramadol is calculated as mg and administered intravenously.
次要结局
- Change from Baseline Heart Rate(Intraoperative)
- Incidence of shoulder pain(24 hours)
- Change from baseline Mean Blood Pressure(Intraoperative)
- Incidence of sedation and respiratory depression(24 hours)
- Incidence of headache and dizziness(24 hours)
- Change in depth of anesthesia(Intraoperative)
- Incidence of Nausea and Vomiting(24 hours)
- Postoperative pain(24 hrs after the procedure)
- Side effect related to administration of lidocaine(24 hours)
研究者
Ioannis Baloyiannis
Assistant Professor of Surgery
Larissa University Hospital