NCT01501565已完成4 期
Ultrasound-guided Analgesic Transverse Abdominal Plain Blockade in the Multimodal Pain Management for Laparoscopic Urological Surgery. Analgesic Efficacy Assessment.
Fundacio Puigvert2 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 2
- 主要终点
- Pain level
研究概览
简要总结
The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 yrs.
- •Patients undergo laparoscopic urologic surgery
- •Physical status ASA < 3
- •Surgical procedure without complications
- •Signed informed consent
排除标准
- •Allergy to bupivacaine chlorhydrate
- •Patients with chronic pain treatment
- •Alcoholism
- •Decompensated hepatic disease
- •Coagulation disorders
- •BMI > 35
- •Patient involved in another clinical trial
结局指标
主要结局
Pain level
时间窗: Change in pain from admittance to 24 hours postoperatively
Pain is assessed by numerical scale (0 to 10) where 0 is no pain and 10 is the most intense pain possible. Pain will be assessed at 4, 6 , 8, 12 and 24 hours.
次要结局
- Analgesic consumption as a rescue therapy(within 24 postoperative hours)
- Incidence of postoperative nausea and vomiting (PONV) related to therapy(within 24 postoperative hours)
- Incidence of urethral/bladder spasm(within 24 postoperative hours)
- Assessment of oral intake tolerance(within 24 postoperative hours)
- Patient satisfaction(within 24 postoperative hours)
研究者
Juan Francisco Mayoral Farre
Principal Investigator
Fundacio Puigvert
研究点 (2)
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