Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Opioid consumption during 24 hours after the surgery
研究概览
简要总结
Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance.
The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in post operative period of abdominoplasty.
详细描述
To determine if TAP block have an analgesic effect in post operative period of abdominoplasty this study was made versus placebo: one group of patients will have a TAP block of levobupivacaine, the second group will have a TAP block with placebo before the surgery. Patient follow up includes data collected before surgery (at pré anesthesic visit and just before surgery) and data collected immediately after surgery (at post operative time) and at distance of the surgery (15 days and 3 months after the surgery). The principal aim is to show if TAP block have an analgesic effect in post operative period after abdominoplasty. To answer this question we will compare opioid intake during the two days after the surgery between the two groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA1 or 2 patients
- •Undergoing abdominoplasty surgery in Centre François Xavier Michelet at Bordeaux University hospital
- •Age >18 years old
- •Patient agreement by signing an informed consent
排除标准
- •Psychiatric or neurological disease
- •Contraindication to regional anesthesia (haemostatic disorders, infection near to insertion point)
- •Double surgery
- •Long term opioid therapy
- •Pregnancy or breast-feeding
- •Allergy to any drug used in anesthesic or surgical procedure
研究组 & 干预措施
TAP Block with levobupivacaïne
干预措施: TAP Block (Procedure)
TAP Block with Placebo
干预措施: TAP Block (Procedure)
结局指标
主要结局
Opioid consumption during 24 hours after the surgery
时间窗: 24 hours after surgery
次要结局
- Quality of analgesia(Until 48 hours after surgery)
- Early rehabilitation : hour of first rising, six-minute walk test at 3days and at discharge(Until discharge, up to 8 days after surgery)
- Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area(15 days and 3 month after surgery)
- Health - related quality of life preoperative and at 3 months post operatively(Just before and 3 months after surgery)