The Effect and Safety of the Four Points Transversus Abdominis Plane Block Under the Ultrasound Guidance in Postoperative Analgesia to the Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The consumption of sulfentanil (mean)
研究概览
简要总结
The anterior abdominal wall from below the xiphoid to infraumbilical area is dominated by the sensory nerves which originate from the anterior rami of the thoracolumbar spinal nerves from T6-L1. The branches nerves from T7-T12 are between aponeurosis internal oblique and transversus abdominal muscle. They can be approached with the ultrasound guidance at subcostal and lateral abdominal wall position.
The bilateral transversus abdominis plane (TAP) block has been demonstrated effectiveness and safety in postoperative analgesia to the under abdominal surgery. However, the effect of one to the upper abdominal surgery is unclear.
The four points TAP block has been described the first in 2010. The effect of the four points TAP block in postoperative analgesia to the upper abdominal surgery has been reported in recent years. Besides, the effect of thoracic paravertebral block (PVB) in postoperative analgesia to liver resection was also reported. The both techniques have been performing in some studies. The effect and safety of the both techniques have been reported. However, the evidence level is still weak. The investigators need to find a technique, which has effectiveness as well as safety to replace the epidural analgesia, which was confirmed that had many complications, in postoperative analgesia to the hepatectomy.
The investigators hypothesized that the four points TAP block under the ultrasound guidance has more effectiveness than the thoracic paravertebral block in postoperative analgesia to the hepatectomy.
详细描述
This is a randomized, controlled, no blind, clinical trial. The study was approved by Board of Scientists and Ethic Council in Gia Dinh People Hospital on May 28, 2018. The written informed consent will be obtained from all subjects participating in the trial. The trial will be registered prior to patient enrollment at Gia Dinh People Hospital.
The investigators will select 60 participants who are selective hepatectomy with the "J-shape" incision, II-III of Anesthesiologists Society America (ASA), from 18-75 age. The cases have chronic pain, tolerance opioids, psychology disorder, and allergy opioids or ropivacaine will excluded. All of participants will be randomly divided two groups. There are TAP group and PVB group. Each one has 30 cases.
General anesthesia:
All of cases will be examined, prepared, supplied the study's information on the day before surgical date. The cases, who have enough selective standard, will be selected.
In the operating room, the participants will be performed general anesthesia The participants will be started anesthesia with 1 mg of midazolam, 0.3 mcg/kg of sufentanil, 1-1.5 mg/kg of propofol, and 0.6 mg/kg of rocuronium. Then, the participants will be maintained anesthesia with sevoflurane, sufentanil, and rocuronium. The end of surgery, they will be prevented postoperative nausea and vomiting with 4 mg of ondansetron; and reversed residual of muscle relaxant with sugammadex.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects has selective hepatectomy
- •Subjects has had II-III of Anesthesiologists Society Americans
排除标准
- •History of chronic pain
- •History of tolerance opioids
- •History of psychology disorder
- •Allergic to ropivacaine or opioids
研究组 & 干预措施
TAP group
The TAP block is performed under the ultrasound guidance at four points: at subcostal and lateral abdominal wall at right-side and left-side.
Drug: ropivacaine 0.375% 40 ml (maximum dose <= 3 mg/kg). Maintenance: ropivacaine 0.375% 8 ml/hour during 48 hours.
干预措施: TAP (Procedure)
TAP group
The TAP block is performed under the ultrasound guidance at four points: at subcostal and lateral abdominal wall at right-side and left-side.
Drug: ropivacaine 0.375% 40 ml (maximum dose <= 3 mg/kg). Maintenance: ropivacaine 0.375% 8 ml/hour during 48 hours.
干预措施: Ropivacaine (Drug)
TAP group
The TAP block is performed under the ultrasound guidance at four points: at subcostal and lateral abdominal wall at right-side and left-side.
Drug: ropivacaine 0.375% 40 ml (maximum dose <= 3 mg/kg). Maintenance: ropivacaine 0.375% 8 ml/hour during 48 hours.
干预措施: Sufentanil (Drug)
PVB group
The paravertebral block is performed under the ultrasound guidance at T7. Drug: ropivacaine 0.5% 20 ml (maximum dose <= 3 mg/kg). Maintenance: ropivacaine 0.25% 8 ml/hour during 48 hours.
干预措施: PVB (Procedure)
PVB group
The paravertebral block is performed under the ultrasound guidance at T7. Drug: ropivacaine 0.5% 20 ml (maximum dose <= 3 mg/kg). Maintenance: ropivacaine 0.25% 8 ml/hour during 48 hours.
干预措施: Ropivacaine (Drug)
PVB group
The paravertebral block is performed under the ultrasound guidance at T7. Drug: ropivacaine 0.5% 20 ml (maximum dose <= 3 mg/kg). Maintenance: ropivacaine 0.25% 8 ml/hour during 48 hours.
干预措施: Sufentanil (Drug)
结局指标
主要结局
The consumption of sulfentanil (mean)
时间窗: 24 hours
The consumption of sufentanil is total dose of sufentanil which the participant used during 24 hours. Sufentanil is intravenously infused with PCA, with single dose 1 mcg, limit dose 8 mcg per a hour, and lockout time 5 minutes.
次要结局
- Side-effect of sulfentanil (frequency)(48 hours)
- Satisfaction (mean)(24 hours)
- The complications of technique (frequency)(24 hours)
研究者
BINH HUYNH
Department of Anesthesiology
Gia Dinh People Hospital