Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- postoperative pain score
研究概览
简要总结
This study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain management after laparoscopic cholecystectomy. Half of patients will receive intravenous lidocaine during procedure, the rest half of patients will receive regular anesthesia care and placebo treatment.
详细描述
Postoperative pain and ileus are primary reasons for delayed patient recovery and longer hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this patient population. However, opioid administration can exacerbate postoperative ileus and further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore recommended for pain control after abdominal surgery to reduce opioid consumption and opioid-related adverse effects.
Studies have reported that systemically administered lidocaine has analgesic, anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published that evaluated systemically administered lidocaine for postoperative pain management and recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine for postoperative recovery remains controversial. Therefore, the investigators performed this study to evaluate the efficacy of systemic administration of lidocaine for postoperative analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators primary hypothesis is that systemic lidocaine administration reduces pain intensity following 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist (ASA) status I-II adult patients undergoing elective laparoscopic cholecystectomy.
排除标准
- •Open surgery;
- •Patients allergic to lidocaine or other local anesthetics;
- •Drug abuser.
研究组 & 干预措施
intravenous lidocaine
intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.
干预措施: Lidocaine (Drug)
saline placebo
same amount volume saline infusion
干预措施: Saline Placebo (Drug)
结局指标
主要结局
postoperative pain score
时间窗: 72 hours after surgery
visual analogue score (1-10)
total postoperative opioid consumption
时间窗: 48 hours after surgery
postoperative fentanyl consumption
次要结局
- incidence of postoperative complication(48 hours after surgery)
研究者
YANXIA SUN
Vice-Chief Anesthesiologist
Beijing Tongren Hospital
