NCT00772291已完成3 期
Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- pain
研究概览
简要总结
Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of unilateral inguinal herniotomy
- •Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score
- •Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area
- •Duration pain ≥ 3 months
- •Medial or lateral inguinal hernia
- •Age ≥ 18 years
- •VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today'
- •Grade III or IV pain and discomfort on the 4-point pain and discomfort scale
- •Informed consent (addendum V)
排除标准
- •Participation in another trial
- •Age < 18 years
- •Cognitive disfunction
- •Patient is unable to speak Dutch
- •Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
- •Patient classified as American Society of Anaesthesiologist Class 4
- •Renal impairment
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: placebo (Drug)
pregabalin
Active Comparator
干预措施: pregabalin (Drug)
结局指标
主要结局
pain
时间窗: 8 weeks
次要结局
- quantitative sensory testing (QST) accuracy in testing the inguinal region(8 weeks)
研究者
hasan eker
Prof. Dr. J.F. Lange
Erasmus Medical Center
研究点 (1)
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