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临床试验/NCT02997215
NCT02997215Unknown4 期

Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy

Beijing Tongren Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Placebo Comparator

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

发起方
Beijing Tongren Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

YANXIA SUN

Vice-Chief Anesthesiologist

Beijing Tongren Hospital

研究点 (1)

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