跳至主要内容
临床试验/NCT01501565
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

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

发起方
Fundacio Puigvert
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juan Francisco Mayoral Farre

Principal Investigator

Fundacio Puigvert

研究点 (2)

Loading locations...

相似试验