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临床试验/NCT02055664
NCT02055664已完成4 期

THE TAP BLOCK TECHNIQUE VIA THE ANTERIOR APPROACH IN ELECTIVE SURGERY OF THE SPINE: Prospective, Randomised, Double Blind Trial, Comparing TAP BLOCK With Continuous Infiltration of Ropivacaine Versus Placebo

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年1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
80
试验地点
1
主要终点
Consumption of morphine in mg

研究概览

简要总结

This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo.

Procedure:

Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.

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

  • Patients over 18 yo who have provided written informed consent
  • Patients with an indication for elective spinal surgery using laparotomy
  • Patients with national health insurance cover

排除标准

  • Adults under guardianship
  • Pregnant or breast-feeding women
  • allergies or contra-indication for paracetamol, morphine-based drugs
  • Contra-indication for ropivacaine
  • Contra-indication for sodium chloride
  • inability to understand PCA (patient-controlled anaesthesia)
  • Hypersensitivity to ropivacaine or to other aminoamide local anaesthetics
  • Hypovolemia

研究组 & 干预措施

treatment

Experimental

干预措施: Chlorure de sodium 0.9% (Drug)

control

Placebo Comparator

干预措施: Ropivacaine 0.2% (Drug)

结局指标

主要结局

Consumption of morphine in mg

时间窗: First 48 hours following the surgery

次要结局

  • Intensity of pain(First 48 hours following the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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