NCT03128216Unknown不适用
Comparison of Local Anesthetic Infiltration, Trasversalis Fascia Block or Spinal Anesthesia for Inguinal Hernia Repair
Istituti Ospitalieri di Cremona1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年4月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Hospital discharge
研究概览
简要总结
Propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided Transversals Fascia Block and Spinal Anesthesia in patients undergoing to inguinal hernia repair surgery. The effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.
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
- Double (Care Provider, Investigator)
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
- •age> 18 years;
- •ASA score I - II - III;
- •patients undergoing elective inguinal hernia repair;
- •signed informed consent;
排除标准
- •chronic therapy with opioids/ antidepressants;
- •urgent/emergent surgery;
- •postoperative transfer to the intensive care unit;
- •known allergy to any drug medication;
- •local skin infection;
- •epilepsy;
- •alcohol or drug abuse;
研究组 & 干预措施
Blind Local Anesthetic Infiltration
Active Comparator
干预措施: Blind Local Anesthetic infiltration (Procedure)
Blind Local Anesthetic Infiltration
Active Comparator
干预措施: Ropivacaine (Drug)
Transversals Fascia Block
Active Comparator
干预措施: Transversals Fascia Block (Procedure)
Transversals Fascia Block
Active Comparator
干预措施: Ropivacaine (Drug)
Spinal Anesthesia
Active Comparator
干预措施: Spinal Anesthesia (Procedure)
Spinal Anesthesia
Active Comparator
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Hospital discharge
时间窗: First 6 post-operative hours
Time need to reach hospital discharge criteria in post-operative period
次要结局
- Post-operative Pain(Post-operative period for 6 hours, every 30 min)
- Intraoperative Pain Control(Intraoperative period)
- Side effects(intra-operative and post-operative period (6 hours))
- Chronic Pain(at 1 week and 3 months in post-operative period)
研究者
Erika Basso Ricci
Principal Investigator
Istituti Ospitalieri di Cremona
研究点 (1)
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