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临床试验/NCT05936190
NCT05936190招募中不适用

Comparison of the Effect of Lidocaine Infusion Applied at Different Doses During Lumbar Spinal Surgery on Hemodynamics and Postoperative Pain

Ankara University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月10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
80
试验地点
1
主要终点
Assessing Postoperative pain with the pain scoring system (Visual Pain Scale).

研究概览

简要总结

The aim of this study is to investigate the effects of intravenous infusion of lidocaine at different doses (1 mg/kg/h vs. 2 mg/kg/h) in the intraoperative period in patients undergoing lumbar stabilization, whether postoperative pain, postoperative opioid use, opioid-related side effects are reduced, and its effects on intraoperative hemodynamics

详细描述

Lumbar stabilization surgery is among the surgical interventions with a high incidence of postoperative pain. Controlling postoperative pain and ensuring early recovery are important in terms of early neurological evaluation. It has been shown that lidocaine infusion administered during the intraoperative period causes peripheral vasodilation, synaptic transmission inhibition, and an increase in the depth of anesthesia. Because of these effects, the effects of lidocaine infusion on hemodynamic responses and recovery have been investigated. The safe dose range of lidocaine is 1-4 mg/kg, and the toxic dose is 5 mg/kg and above. Many studies have shown that lidocaine infusion suppresses the sympathetic reflex response and has a depressive effect on the cardiovascular system. In a study evaluating patients who underwent open radical prostatectomy surgery, it was found that blood pressure values were lower in patients who received intraoperative lidocaine infusion compared to the control group. In a study evaluating 60 female patients who underwent breast surgery, it was shown that the mean blood pressure value was significantly lower in patients who received lidocaine infusion. Lidocaine infusion has been applied at different doses (2-3 mg/kg/hour) and at different times in different surgical procedures, and it has been shown to be more effective in reducing postoperative pain, especially in some surgical procedures. Studies showing that lidocaine infusion provides early recovery in the perioperative period; They explain this effect of lidocaine by reducing the need for opioids and reducing the complications that affect the quality of recovery, such as opioid-related nausea and vomiting. It has been shown that 2 mg/kg/hour lidocaine infusion in patients undergoing vertebral surgery provides early and high-quality recovery by reducing the opioid requirement and reducing pain scores. In a study conducted in patients undergoing spinal fusion surgery, lidocaine was administered as a bolus of 2 mg/kg in the induction of anesthesia and infusion of 3 mg/kg/hour in the intraoperative period until the end of the surgery. Compared to the control group, the first additional analgesic need emerged later and the total amount of morphine consumption was found to be lower. Although there are studies in the literature using different doses of lidocaine in different surgeries, there are limited data on the effect of different doses of lidocaine on intraoperative postoperative pain and hemodynamics in patients who underwent vertebral surgery. In our study, we aimed to investigate the effect of different doses of lidocaine infusion (1 mg/kg/hour and 2 mg/kg/hour) on postoperative pain changes and hemodynamics. The main aim of the study is to evaluate whether 2 mg/kg/h lidocaine infusion doses reduce postoperative pain severity more than 1 mg/kg/h infusion doses in patients undergoing lumbar stabilization surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Participant, 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

  • 未提供

排除标准

  • ASA 3,4,5
  • Pediatric Patients

研究组 & 干预措施

Group L1

Active Comparator

Group who gets 1 mg/kg/min IV lidocaine infusion during surgery

干预措施: Lidocaine (Drug)

Group L2

Experimental

Group who gets 2 mg/kg/min IV lidocaine infusion during surgery

干预措施: Lidocaine IV (Drug)

结局指标

主要结局

Assessing Postoperative pain with the pain scoring system (Visual Pain Scale).

时间窗: 24 hours

The primary endpoint was the evaluation and comparison of two different infusion doses (2 mg/kg/hr and 1 mg/kg/hr) of postoperative pain with the pain scoring system (Visual Pain Scale).

次要结局

  • Monitoring Intraoperative blood pressure(2 hours)
  • Monitoring intraoperative heart rate(2 hours)

研究者

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

Süheyla Karadağ Erkoç

Anesthesiology and Reanimation

Ankara University

研究点 (1)

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