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临床试验/NCT01278264
NCT01278264Unknown4 期

Transversus Abdominis Plane Blocks in Patients Scheduled for an Abdominoplasty. A Prospective, Randomized, Double Blind, Comparison Between the Posterior Approach and Placebo.

Clinique Saint-Jean, Bruxelles1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
60
试验地点
1
主要终点
Morphine consumption

研究概览

简要总结

Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty.

详细描述

TAP blocks have the potential to become an important part of multi-modal analgesia after abdominal surgery (1,2). Originally Dr J McDonnell described a blind double pop technique, trough the triangle of Petit, with up to 48 hours of analgesia (3,4). Dr P Hebbard described an ultrasound based technique with a subcostal (for supra-umbilical analgesia) and an axillary mid-line injection (for sub-umbilical analgesia) in the TAP, with reported analgesia for up to 8 hours (5,6). Recently Dr J McDonnell presented data showing para vertebral spread (up to L5) of the (high dose, low concentration) local anaesthetic explaining the prolonged analgesic effect (7,8). In 2007 Dr Blanco described an ultrasound guided technique for the posterior infiltration as performed by McDonnell (9). Our limited observational comparison between both block techniques confirms this difference. We decided to compare both techniques (the ultrasound guided single shot subcostal injection, the aTAP-group (Hebbard is from Australia) and the ultrasound guided posterior injection, the iTAP-group (McDonnell is from Ireland). We will use the same volume and concentration of local anesthetic and we will asses their analgesic efficacy and improvement in quality of recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Eligible for abdominoplasty
  • Fluent french/dutch/english

排除标准

  • History of allergy to local anaesthetics
  • Chronic opioids abuse
  • Pregnant patients

研究组 & 干预措施

iTAP-group

Active Comparator

Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle

干预措施: Ropivacaine 0.25%, 0.5 ml/kg (Drug)

aTAP-group

Active Comparator

Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet

干预措施: Ropivacaine 0.25%, 0.5 ml/kg (Drug)

结局指标

主要结局

Morphine consumption

时间窗: 48 hours

Consumption measured by the use of the PCA pump

次要结局

  • VAS score(48 hours)
  • Post operative nausea and vomiting(48 hours)
  • Constipation(48 hours)
  • Pruritus(48 hours)
  • First time to get up(48 hours)
  • First time to eat(48 hours)

研究者

发起方
Clinique Saint-Jean, Bruxelles
申办方类型
Other

研究点 (1)

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