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临床试验/NCT01529190
NCT01529190已完成2 期

Effect of Preoperative Pregabalin on Pain Intensity and Interleukin-6 Levels in Living Donor Kidney

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Effect of preoperative pregabalin on pain intensity in living donor kidney

研究概览

简要总结

Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central sensitization. The IL-6, is detectable 60 minutes after surgical incision, persisting for until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective of this study is evaluating the analgesic effect of pregabalin and its repercussion on serum levels of IL6.

详细描述

After approved by the Ethical Committee and signed informed consent, 40 patients aged from 18 until 60 years undergoing nephrectomy will be randomized in two groups. Group 1 patients will receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2 patients will receive a placebo dose. Pain intensity will be assessed with the numeric rating scale. The consumption of tramadol in 24 hours after surgery and the time for the first complementation dose will be registered. Blood samples will be collected by 6 hours and 24 hours after surgical incision, for IL-6 dosage, and maintained at -70 celsus degree. The IL-6 dosages will be performed by the ELISA (enzyme-linked immunosorbent assay) method. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.

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, Care Provider, Investigator)

入排标准

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

入选标准

  • living donor kidney

排除标准

  • myocardial ischemia
  • psychiatric disease
  • absence of chronic pain
  • absence of drugs dependency
  • don´t use of opioid medication 1 week before surgery

研究组 & 干预措施

pregabalin 300mg

Active Comparator

Group 1 patients will receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2 patients will receive a placebo dose. Pain intensity will be assessed with the numeric rating scale. The consumption of tramadol in 24 hours after surgery and the time for the first complementation dose will be registered. Blood samples will be collected by 6 hours and 24 hours after surgical incision, for IL-6 dosage, and maintained at -70 celsus degree

干预措施: Pregabalin (Drug)

sugar pill

Placebo Comparator

group 2 will receive a placebo dose, 1 hour before tue surgical icnision

干预措施: Placebo (Drug)

结局指标

主要结局

Effect of preoperative pregabalin on pain intensity in living donor kidney

时间窗: first 24 hours after surgery

次要结局

  • Effect of preoperative pregabalin on interleukin-6 levels in living donor kidney(first 24 hours after surgery)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Ellen de Queiroz Santiago

medical resident, principal investigator

Federal University of São Paulo

研究点 (1)

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