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临床试验/NCT01862354
NCT01862354Unknown不适用

Comparative Analgesic Effect Between Continuous Wound Infusion and Transverse Abdominal Plan Block for Abdominoplasty Surgery

University of Liege2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Pain score expressed on a visual analogue scale

研究概览

简要总结

The purpose of this randomized controlled study is to compare the postoperative analgesic effect of a continuous wound infusion of local anesthetics and a sole transverse abdominal plan (TAP) regional block in the surgery of Abdominoplasty Combined With Flank Liposuction. Local anesthetics products used are ropivacaine combined with clonidine. Similar amount of local anesthetics and clonidine are used.

详细描述

In a first group, patients receive, after induction of anaesthesia and before surgery, a TAP block (transverse abdominal plan block) with 3mg/kg Ropivacaine 0.5% (maximum 200 mg) and 150 microg Clonidine.

In a second group, before skin closure, a multiholes catheter was inserted beyond the skin. 20 mg Ropivacaine 0.2% added with 150 microg Clonidine was injected as bolus dose through this catheter followed by a continuous infusion of Ropivacaine 0.2% 10ml per hour during the following 9 hours (total dose of 200 mgr).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients scheduled for abdominoplasty combined with flank liposuction

排除标准

  • Allergy to local anesthetics or clonidine
  • Coagulation disorders
  • History of chronic pain
  • Alcohol or drugs dependance
  • Refusal of the patients

结局指标

主要结局

Pain score expressed on a visual analogue scale

时间窗: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively

次要结局

  • Piritramide consumption on Patient Controlled Analgesia (PCA) device(at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively)
  • Scale of nausea(at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively)
  • Scale of sedation(at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively)
  • Scale of patient's satisfaction(at day 2 postoperatively)
  • Number of patients with adverse events(daily during 48 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

J P Lecoq

MD

University of Liege

研究点 (2)

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