Randomised Study of Noninferiority Comparing a TransversusAbdominis Plane Block Surgical (c-TAP Block) to the Ultrasound-guided Abdominis Plane Block Transversus (Us-TAP Block) in Postoperative Analgesia After Laparoscopy or Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure
研究概览
简要总结
Interventional, randomised, prospective, multicentric study
详细描述
Interventional, randomised, prospective, multicentric and single blind study
Primary objective :
demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia
Secondary objective :
- Assess the effectiveness of c-TAP block on us-TAP Block in the obese and/or malnourished patient subgroup
- Compare the running time of the c-TAP Block to the us-TAP Block
- Assess the safety of the c-TAP Block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups:
- Arm A : c-TAP Block performed by the surgeon
- Arm B : us-TAP Block performed by the anesthesist under ultrasound control
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
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
- •Patient over 18 years old
- •Patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital.
- •Patient mastering the French language
- •Patient who received informed information about the study and signed a consent
- •Patient affiliated to a social security scheme.
排除标准
- •Patients with chronic pain
- •Patients with opioid dependence
- •Patients allergic to local anesthetic
- •Patient who has not signed the consent of the study.
研究组 & 干预措施
Arm A : c-TAP Block performed by surgeon
c-TAP Block Block performed by surgeon
干预措施: laparoscopy or laparotomy withTransversusAbdominis Plane Block (Procedure)
Arm B : us-TAP Block performed by anesthetist
us-TAP Block by anesthetist
干预措施: laparoscopy or laparotomy withTransversusAbdominis Plane Block (Procedure)
结局指标
主要结局
Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure
时间窗: 24 hours
Evolution pain intensity scores, assessed by the numerical pain scale (EN 1 up to 10)
次要结局
- Failure rate in the obese and / or malnourished patient subgroup(24 hours)
- Time in minutes of each of the TAP Block techniques(24 hours)
- Occurrence of trauma to the intra-abdominal organs caused by the injection needle(24 hours)