Effect of Endovenous Lidocaine on Analgesia and Serum Cytokines Concentration: Randomized and Double-blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
研究概览
简要总结
Ineffective treatment of postoperative pain may cause organic damage and chronic pain. Nevertheless, opioids, the leading drugs used for this purpose, present side effects that sometimes restrict their usability. In a multimodal context, new postoperative analgesia techniques have been developed focusing in the reduction of opioid use and their adverse effects, as well as postoperative chronic pain prevention. In this background, continuous intravenous infusion of lidocaine during perioperative period has shown to be promising. This trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus and length of hospital stay and IL-1, IL-6, IL-10, α TNF and γ IFN levels in patients undergoing to laparoscopic cholecystectomies who received intravenous lidocaine in comparison to a control group. Intravenous lidocaine in the perioperative period of laparoscopic cholecystectomies was not able to reduce postoperative pain, opioid consumption, and duration of ileus or length of hospital stay. However, its anti-inflammatory effect was evidenced by the significant changes in the studied cytokines.
详细描述
Forty-four patients undergoing laparoscopic cholecystectomy, under general anesthesia, were randomly allocated in two groups. The first group received intravenous lidocaine infusion during the procedure until one hour postoperatively; meanwhile the second group received intravenous saline for the same period of time. The intervention was double-blind. In the postoperative period, both groups received dipyrone and morphine PCA. Pain was assessed by Visual Numeric Scale (VNS) at rest and when coughing at 1st, 2nd, 4th, 12th e 24th hour after the end of the surgery. Blood samples for cytokines measurement were taken at the end of procedure and 24 hours later. The total morphine PCA demand, the time for the first flatus and the length of hospital stay were also recorded and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years and
- •physical status according to the American Society of Anesthesiologists (ASA) I and II
排除标准
- •patients older than 75 years,
- •patients with heart disease,
- •patients with history of:
- •kidney failure,
- •liver failure,
- •psychiatric disorder,
- •chronic use of opioids or medications that could cause induction of liver enzymes (anticonvulsants).
- •the presentation of adverse effects during the intervention or postoperative complications, and the conversion to open surgery.
研究组 & 干预措施
Lidocaine
Group treated with lidocaine solution
干预措施: Lidocaine (Drug)
Placebo
Group treated with saline solution
干预措施: Saline solution (Drug)
结局指标
主要结局
The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
时间窗: 24 hours
The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
次要结局
- The secondary outcome was measure of citokynes IL-10 levels(24 hours)
- The secondary outcome was measure of citokynes TNF levels(24 hours)
- The secondary outcome was measure of citokynes IL-1 levels(24 hours.)
- The secondary outcome was measure of citokynes IL-6 levels(24 hours)
- The secondary outcome was measure of citokynes IFN γ levels(24 hours)
研究者
Juliano Ferreira
PhD
Universidade Federal de Santa Maria