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临床试验/NCT05369650
NCT05369650Unknown不适用

A Pilot Study on the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine for Postoperative Analgesia in Patients With Open Hepatectomy

West China Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年7月27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
入组人数
120
试验地点
1
主要终点
Immediate postoperative plasma lidocaine concentration

研究概览

简要总结

All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.

详细描述

All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml. All the background infusions of PCIA will set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

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)

盲法说明

The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.

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

  • Age: 18-70 years old
  • American Society of Anesthesiologists(ASA) Ⅰ~III
  • Intended for open liver resection Exclusion criteria:
  • Long-term opioid users
  • Patients with contraindications or allergies to any drugs (lidocaine, etc.) used in this study
  • Patients with severe hepatic insufficiency before surgery (defined as total bilirubin>1.46mg/dl), renal insufficiency (glomerular filtration rate <30ml/min/1.73m2 or end-stage renal disease)
  • Associated with severe heart disease (second or third degree atrioventricular block); severe heart failure (ejection fraction <50%); sinus bradycardia; patient
  • Patients who participated in other clinical trials within 3 months before enrollment in the study.

排除标准

  • 未提供

研究组 & 干预措施

Lidocaine 1 group

Experimental

After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation.

干预措施: Lidocaine Hydrochloride, Injectable (Drug)

Lidocaine 1.5 group

Experimental

After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1.5mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation.

干预措施: Lidocaine Hydrochloride, Injectable (Drug)

Lidocaine 2 group

Experimental

After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 2mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation.

干预措施: Lidocaine Hydrochloride, Injectable (Drug)

结局指标

主要结局

Immediate postoperative plasma lidocaine concentration

时间窗: Immediately after surgery

Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use

次要结局

  • 24-hour postoperative plasma lidocaine concentration(24-hour postoperative)
  • The incidence of moderate to severe pain at 24、48 and 72 hours after surgery at rest and during movement;(24,48 and 72 hours after surgery)
  • Bowel function recovery(At 3 days after surgery)
  • The incidence of lidocaine toxicity within 72 hours after operation(within 72 hours after operation)
  • Plasma lidocaine concentration immediately after loading(30 minutes before surgery)
  • The cumulative morphine consumption at 24, 48 and 72 hours postoperatively(At the end of the surgery,24,48 and 72 hours after surgery)
  • Postoperative hospital stay(up to 30 days)
  • Patient satisfaction scores(72 hours after surgery)

研究者

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

Chunling Jiang

Professor

West China Hospital

研究点 (1)

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