Effect of Intravenous Lidocaine Infusion on Postoperative Inflammatory Response in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Double Blind Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative CRP level
研究概览
简要总结
This study aims to evaluate the analgesic and anti-inflammatory effect of perioperative intravenous lidocaine infusion and in turn the return of gastric motility in patients undergoing elective laparoscopic cholecystectomy.
详细描述
Laparoscopic cholecystectomy is considered a minimally invasive procedure; however, it still provokes a measurable systemic inflammatory response. This reaction is primarily driven by factors such as tissue manipulation, peritoneal insufflation, and surgical stress. C-reactive protein (CRP), a widely validated acute-phase reactant, serves as a reliable biomarker to monitor postoperative inflammation, typically peaking within 24 to 48 hours following surgery. Other inflammatory markers such as white blood cell (WBC) count, neutrophil-to-lymphocyte ratio (NLR), and interleukin-6 (IL-6) also exhibit perioperative changes, reflecting the underlying cytokine-mediated stress response. Monitoring these biomarkers provides insight into the extent of tissue injury and can help predict postoperative recovery or complications. Therefore, modulating the inflammatory response-such as through intravenous lidocaine infusion-may improve postoperative outcomes, including pain control, gastrointestinal recovery, and length of hospital stay.
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, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 - 60 years
- •Elective laparoscopic cholecystectomy for symptomatic cholelithiasis or chronic cholecystitis
- •ASA physical status I-II
- •BMI < 35 kg/m2
- •Preoperative CRP <20 mg/L
- •Informed consent provided
排除标准
- •Acute cholecystitis or biliary pancreatitis
- •Conversion to open surgery
- •Pre-op CRP >20 mg/L
- •Allergy to lidocaine or local anesthetics
- •Known hepatic or renal dysfunction
- •Chronic inflammatory conditions
- •Current immunosuppressive therapy
- •Cardiac arrhythmias or heart block without pacemaker
- •ASA physical status III, IV or above
- •Pregnancy or breastfeeding
- •Psychiatric disorders
研究组 & 干预措施
Group L
IV Lidocaine infusion:
干预措施: IV Lidocaine infusion (Drug)
Group C
IV normal saline
干预措施: IV normal saline (Drug)
结局指标
主要结局
Postoperative CRP level
时间窗: postoperative day 1 (24 hours postoperative)
measurement of Postoperative CRP level
次要结局
- Pain scores (VNS)(2, 6, 12, 24 hours)
- GIT motility(within 24 hours)
- Postoperative complications(within 48 hours)
- Time to ambulation(within 48 hours)
研究者
Noha Yahia Mohammd El-hagagy
Lecturer of anesthesia and intensive care, faculty of medicine, Assiut university.
Assiut University