NCT01326039Unknown4 期
Does Ultrasound-guided Ilioinguinal-iliohypogastric Block Improve Postoperative Pain Outcome After Unilateral Inguinal Hernia Repair?
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain at mobilization using 100 mm VAS
研究概览
简要总结
Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age above 18 years
- •unilateral primary inguinal repair
- •open surgery a.m. Lichtenstein
- •informed consent
排除标准
- •age below 18 years
- •secondary surgery
- •laparoscopic surgery
- •lack of communicative skills
研究组 & 干预措施
bupivacaine
Active Comparator
perineural bupivacaine 5 mg/ml 20 ml
干预措施: bupivacaine (Drug)
saline
Placebo Comparator
perineural isotonic saline 20 ml
干预措施: saline (Drug)
结局指标
主要结局
pain at mobilization using 100 mm VAS
时间窗: within the first 24 hours postoperatively
次要结局
- pain at rest using 100 mm VAS(within 24 hours postoperatively)
- perceived illness(within 24 hours postoperatively)
- ability of daily living(within 24 hours)
- amount of analgesics(within 24 hours postoperatively)
研究者
研究点 (1)
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