Clinical Study of Rhomboid Intercostal and Subserratum Plane Block for Postoperative Analgesia in Minimally Invasive Esophagectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Analgesic effect
研究概览
简要总结
The objective is to investigate the safety and effectiveness of rhomboid intercostal and subserratum plane (RISS) block for postoperative analgesia after minimally invasive McKeown esophagectomy (MIE-McKeown).
详细描述
Rhomboid intercostal and subserratum plane block (RISS) is a nerve block technique in which local anesthetics are injected into the rhomboid-intercostal muscle planes and the serratus anterius-intercostal muscle planes, and the intercostal nerve is blocked by diffusion of local anesthetics. It is confirmed that RISS can provide analgesia not only in the front half of the chest, but also in the upper abdomen. However, the efficacy of RISS in minimally invasive surgery for esophageal cancer has not been proven. The investigators placed catheters on the RISS plane and continuously injected local anesthetics to investigate whether RISS is effective and safe in minimally invasive esophageal cancer surgery.
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
- •Patients received MIE-McKeown surgery and were confirmed by postoperative pathology; Age 18-75 years old
- •body mass index (BMI) : 18.5~23.9kg/m2;
- •American Society of Anesthesiologists (ASA) grade: Ⅰ~Ⅱ;
- •Clear consciousness, no cognitive impairment;
- •Patients informed to participate in the study and signed informed consent.
排除标准
- •Infection of the puncture site, abnormal platelet or coagulation function;
- •Patients with drug allergy involved in this study;
- •Long-term use of analgesic, sedative drugs or a history of heavy drinking;
- •Patients with chronic painful diseases;
- •With severe heart, liver, kidney and lung dysfunction;
- •Infectious diseases, blood, immune, circulatory system diseases; -Communication barriers, can not cooperate with the scale assessment; -
- •Other situations not suitable for this study.
结局指标
主要结局
Analgesic effect
时间窗: 2, 6, 12, 24, and 48 hours after surgery
patient will be asked to rate their pain level at rest and cough respectively using visual analogue scale（VAS）.(0 being no pain, 10 being worst pain imaginable)
Heart rate (HR)
时间窗: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
The Heart rate (HR)on the monitor at different times was recorded.
mean arterial pressure (MAP)
时间窗: before anesthesia induction (T0)， before skin incision（T1）， 5 minutes after skin incision
The mean arterial pressure (MAP)on the monitor at different times was recorded.
次要结局
- nausea or vomiting(24hours after surgery)
- hypotension(24hours after surgery)
- dizziness(24hours after surgery)
- lethargy(24hours after surgery)
- urinary retention(24hours after surgery)
- respiratory depression(24hours after surgery)
- Analgesia satisfaction(24hours after surgery)
研究者
Luo Fuchao
principal
Fuling Central Hospital of Chongqing City