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临床试验/NCT04814745
NCT04814745已完成不适用

Intrathecal Morphine Compared to Intravenous Tramadol and Transversus Abdominal Plane Block for Catheter Related Bladder Discomfort Syndrome

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2020年7月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
catheter related bladder discomfort syndrome

研究概览

简要总结

investigators aim to compare the efficacy of intrathecal morphine, intravenous tramadol and transversus abdominis plane block in the treatment of catheter related bladder discomfort syndrome in patients scheduled for robotic assisted laparoscopic prostatectomy

详细描述

patients scheduled for robot assisted laparoscopic prostatectomy will be treated depending on the belonging group. In the morphine group patients will receive intrathecal morphine 0,15 mg; in the transversus abdominis plane block patients will receive ropivacaine 80 mg; in the tramadol group patients will receive intravenous continuous infusion of tramadol 400 mg for the first 24 hours postoperatively. All data will be collected in the post anesthesia room and in the ward until the first post operative day.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • all patients scheduled for robotic assisted laparoscopic prostatectomy

排除标准

  • coagulation disorders and platelet dysfunction for spinal arm
  • obesity for transversus abdominis plane block arm
  • left ventricular ejection fraction < 30%, end-stage renal disease and neurological disorders for all groups

研究组 & 干预措施

morphine

Active Comparator

morphine 150 mcg will be administered intrathecally before surgery by using a 25 Gauge with acre spinal needle

干预措施: intrathecal infusion (Drug)

tramadol

Active Comparator

tramadol 400 mg will be administered by using an elastomeric pump for 24 hours after surgery

干预措施: Intravenous Infusion (Drug)

ropivacaine

Active Comparator

at the end of surgery transversus abdominis plane block will be performed bilaterally and ropivacaine 80 mg will be used

干预措施: Ropivacaine injection (Drug)

结局指标

主要结局

catheter related bladder discomfort syndrome

时间窗: immediately after surgery

grade 0 to III

次要结局

  • pain relief(immediately after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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