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