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临床试验/NCT05541640
NCT05541640招募中不适用

Effect of Intraoperative Lidocaine Infusion on Inducing Intestinal Motility and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery. A Prospective, Comparative, Randomized Double Blind Controlled Clinical Study

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1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
招募中
入组人数
60
试验地点
1
主要终点
postoperative visual analogue score (VAS SCORE)

研究概览

简要总结

Lidocaine is an amide local anaesthetic and an antiarrhythmic agent, first synthesized in 1942, and after approval for human use was launched in 1948 in Sweden The first observations of post operative analgesic effects of perioperative intravenous lidocaine (IVL) were initially proposed in 1951 subsequently many more enthusiastic reports followed. Postoperative formal clinical evaluations in the perioperative setting were conducted in the late 1950s where IV Lidocaine was demonstrated to have a postoperative analgesic effect without posing the risk of respiratory depression, reducing the occurrence of postoperative nausea and vomiting (PONV), and enhance post-surgical recovery. IV Lidocaine also potentiated the depth of anesthesia and led to a better tolerance of endotracheal intubation.Around 40% of patients experience a delay in resumption of normal bowel function after colorectal surgery. This delay leads to symptoms of nausea, vomiting, constipation, and abdominal distension, which then require unpleasant supportive interventions such as intravenous fluids and nasogastric tube insertion. There is no remedy to address this delay. ALLEGRO, "A placebo-controlled randomized trial of intravenous Lidocainein accelerating Gastrointestinal Recovery surgery," is the latest ongoing multicenter research study across the United Kingdom, investigating the use of intravenous lidocaine to improve recovery after colorectal surgery

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years and older.
  • Both sexes, males and females
  • Patients scheduled for elective intestinal surgery.
  • Body mass index (BMI) 18-30 kg•m-
  • ASA I - II.

排除标准

  • Patient refusal
  • Patients with preoperative gastrointestinal dysfunction.
  • Patients with a history of drug abuse, or long-term opioid use.
  • ASA III and VI
  • Patients with a history of previous gastrointestinal surgery

研究组 & 干预措施

control group

Placebo Comparator

干预措施: normal saline group (Drug)

lidocaine group

Active Comparator

干预措施: lidocaine group (Drug)

结局指标

主要结局

postoperative visual analogue score (VAS SCORE)

时间窗: 24 hour

assessment of postoperative pain will be carried by VAS in which zero=no pain and 10= worst pain ever

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rasha Hamed

asisstant lecturer of anaesthesia and pain management

Assiut University

研究点 (1)

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