Laparoscopic- Vs Ultrasound-guided Transversus Abdominis Plane Block in Laparoscopic Colectomy: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Opioids consumption
研究概览
简要总结
The purpose of this study is to compare the postoperative pain, the time needed and other clinical outcomes in patients who, during laparoscopic colectomy, will be injected with a local anesthetic (Ropivacaine) through an ultrasound guided technique performed by the anaesthesiologist or throught a laparoscopic assisted technique performed by the surgeon
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
- Double (Participant, Care Provider)
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
- •Patients candidates to laparoscopic colorectal surgery
- •Signed informed consent
排除标准
- •Age < 18 years old
- •Pregnancy
- •Allergy to local anaesthetics
- •Spinal or epidural analgesia
- •Acute inflammatory abdominal pathologies
- •Chronic pain syndrome
- •Contraindications to nonsteroidal anti-inflammatory drugs (NSAIDS)
研究组 & 干预措施
Laparoscopic Transversus Abdominis Plane (L-TAP) group
Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under laparoscopic control
干预措施: laparoscopic-assisted Transversus Abdominis Plane (TAP) block (Procedure)
Laparoscopic Transversus Abdominis Plane (L-TAP) group
Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under laparoscopic control
干预措施: Ropivacaine (Drug)
Ultrasound Transversus Abdominis Plane (U-TAP) group
Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under ultrasound control
干预措施: ultrasound-assisted Transversus Abdominis Plane (TAP) block (Procedure)
Ultrasound Transversus Abdominis Plane (U-TAP) group
Patients will undergo the planned laparoscopic colectomy according to the standard of treatment. A solution of 15 ml of Ropivacaine (0.2%) is then injected for postoperative pain under ultrasound control
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Opioids consumption
时间窗: 24 hours from surgery
Opioid consumption measured in morphine milligram equivalents (MME) per day
次要结局
- Time required to perform the (Transversus Abdominis Plane) TAP block(during procedure)
- Opioid consumption within the first 48 hours after the operation(48 hours from surgery)
- postoperative pain(at 3, 6, 12, 24 hours from surgery)
- length of hospital stay(during hospitalization,approximately 6 days)
研究者
Davide La Regina
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona