跳至主要内容
临床试验/NCT04061057
NCT04061057已完成不适用

Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia

Yonsei University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2018年3月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Fentanyl requirement using IV PCA

研究概览

简要总结

Arthroscopic rotator cuff repair is a commonly performed procedure but is known to cause significant postoperative pain. Effective analgesia after rotator cuff repair is crucial in improving the well-being of the patient but also to ensure long-term rehabilitation. The most commonly used analgesic for acute postoperative pain is opioids. However, the use of opioids is accompanied by several side effects which include but are not limited to nausea/vomiting, urinary retention, itching sensation and sometimes dizziness, respiratory depression and hypotension in higher doses. As of late, many efforts are aimed toward decreasing the use of opioids by using multimodal analgesia. Among such methods, intravenous lidocaine has been reported to be effective, safe and economic in various procedures. However, the existing evidence is mostly focused on laparoscopic procedures. The present study aims to find whether perioperative infusion of lidocaine is able to decrease opioid requirements after surgery and also improve postoperative pain compared to placebo in patients undergoing arthroscopic rotator cuff repair.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA class 1-3 adults over 19 years scheduled for elective arthroscopic rotator cuff repair

排除标准

  • Known allergies to lidocaine or propofol
  • Cardia arrhythmia
  • History of epilepsy or seizures
  • Liver/kidney failure
  • History of recent strong opioid use

研究组 & 干预措施

IV lidocaine

Experimental

Perioperative IV lidocaine infusion

干预措施: Lidocaine (Drug)

Normal saline

Placebo Comparator

Perioperative IV normal saline infusion

干预措施: Normal saline (Drug)

结局指标

主要结局

Fentanyl requirement using IV PCA

时间窗: 24hours after surgery

Dose of fentanyl infused via IV PCA machine during first 24 hours after surgery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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