Improvement of Quality of Life After Live Liver Donation by ESP Peri Operative Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- quality of pain relief at mouvement
研究概览
简要总结
Liver donors have a significant risk to develop persistent and chronic pain around 20 to 30% affecting social and professional life (17%) up to 1 year after the surgery.
To donate a part of liver is a beautiful gift reason why the pain relief must be improved.
Meta-analysis showed that the best prevention against post operative chronic pain are the techniques blocking the pain signal (regional anaesthesia) Patients after liver donation are still in pain even in 2020 with the best multimodal analgesia medications.
Erector sinae Plane Block (ESP) ESP will block the signal and improve the pain relief we hope to demonstrate that it will reduce the risk to develop post operative chronic pain and improve the quality of recovery and the quality of life after liver donation
详细描述
- Goals:
Compare quality of pain relief and quality of life between bilateral ESP bilateral catheters Vs Opioid analgesia in donor patients for liver donation. 2. Methodology:
• Selection criteria: Age > 18 years old Be volunteer to donate liver Agree to participate in the trial
• Exclusion criteria: Use of chronic opioids Contra-indication tom perform ESP catheter (Infection near puncture point, Severe thoracic scoliosis, allergie to local anesthestics) A diagnosis of a chronic pain conditionDepression or other psychiatric diagnosis
• Study design: Prospective Randomized Controlled Trial.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age more than 18 and less than 61
- •Be volunteer to donate liver
- •agree to participate to study and consent signed
- •Risk of americain society of anesthesiologists score ASA from 1 to 5 score ASA must be 1 only
排除标准
- •Use of chronic opioid before the surgery
- •A diagnosis of chronic pain condition
- •Contra indication to perform ESP catheter
- •allergy to local anesthestics
- •Depression or psychiatric diagnosis
结局指标
主要结局
quality of pain relief at mouvement
时间窗: from day 0 = day of surgery to day 180
Visual analgesic score at mouvement
quality of pain relief at rest
时间窗: from day 0 = day of surgery to day 180
Visual analgesic score at rest
次要结局
- Quality of recovery(1 month after surgery)
- Duration of hospitalisation(From day = 0 day of the surgery to day to discharge day 15 maximum)
- Opioid consumption(from day 0 to 30 days after the day of surgery)
- Patient satisfaction(1 month after the surgery)
- Quality of life (QOL) after donation(1 months and 3 months after surgery)
研究者
Philippe Macaire
Director of anesthesia and pain management - Anesthesiologist MD
Vinmec Healthcare System