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临床试验/NCT00965796
NCT00965796已完成不适用

Effect of Intraoperative Intravenous Lidocaine on Pain After Hysterectomy

Federal University of São Paulo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Pain

研究概览

简要总结

The objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.

详细描述

Study design A prospective, randomized, double-blind study was conducted according to ethical guidelines for research involving humans. The study was approved by the Ethics Committee of the institution and all patients signed a free informed consent form. The patients were randomly allocated to two groups consisting of the same number of subjects by drawing lots.

One physician prepared the solutions and handed them over to the anesthetist who was unaware of the content of the solutions. The volume of the solutions was the same. The researcher was unaware to which group the patient belonged until the end of the study.

Exclusion criteria Excluded from the study were patients with cardiac arrhythmia; myocardiopathy; altered cardiac conduction; psychiatric, hepatic or respiratory disease; and patients receiving any type of analgesic during the week before surgery.

Patients Forty women (ASA 1 or 2) aged 18 to 60 years undergoing hysterectomy were studied.

Treatment Patients of group 1 (n = 20) received lidocaine (2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA 1 or 2, aged 18 to 60 years undergoing hysterectomy

排除标准

  • Cardiac arrhythmia; myocardiopathy
  • Altered cardiac conduction
  • Psychiatric, hepatic or respiratory disease
  • Patients receiving any type of analgesic during the week before surgery

研究组 & 干预措施

Lidocaine, pain intensity and Saline

Experimental

(2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure

干预措施: Lidocaine (Drug)

结局指标

主要结局

Pain

时间窗: 24hours

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other

研究点 (2)

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