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临床试验/NCT02080728
NCT02080728已完成4 期

Transversus Abdominis Plane Block During Kidney Transplant Surgery: Prospective Controlled Randomized Double-blind Trial Comparing Ropivacaine 0.2% With Placebo.

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年7月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Mesurement of VAS (Visual analogue scale) scores for pain

研究概览

简要总结

The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo.

This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above.

This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double

入排标准

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

入选标准

  • Patient opéré for kidney transplant
  • Patients who have provided written informed consent
  • Patients with national health insurance cover
  • Patients aged 18 years and above

排除标准

  • Pregnant or breast-feeding women
  • allergies/hypersensitivity to paracetamol (or propacetamol chlorhydrate (paracetamol pro-drug) or one of its excipients), to local anesthetics, morphines (or other constituents)
  • patients under guardianship or ward of court

研究组 & 干预措施

TAP-Bloc

Experimental

干预措施: Ropivacaine 500mg/100ml Naropeine (Drug)

Control

Placebo Comparator

干预措施: 0.9% sodium chloride BAXTER (Drug)

结局指标

主要结局

Mesurement of VAS (Visual analogue scale) scores for pain

时间窗: During the first 24 hours post-op

次要结局

  • Measurement of analgesic consomption(During the first 24 hours post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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