Efficacy and Safety of Erector Spinal Plane Block (ESPB) for Intraoperative and Postoperative Analgesia in Laparoscopic Cholecystectomy : A Randomized, Single-blind，Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 主要终点
- Pain intensity at rest(Hour 2)
研究概览
简要总结
Purpose: to evaluate the efficacy and safety of erector spinal block (ESB) for analgesia in laparoscopic cholecystectomy（LC）.
Method: This study is a randomized, single-blind, controlled clinical trial. Pre-operative ultrasound-guided bilateral erector spinae plane block will be performed in the ESPB group. Vertebral side block will be performed in the VSB group. And the control group will receive local anaesthesia after the surgery. Intraoperative and postoperative analgesia effect and side effects will be compared between the three groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1-3
- •Scheduled for elective laparoscopic cholecystectomy surgery under general anesthesia
排除标准
- •patient refusal
- •pregnancy
- •history of allergy to study drugs
- •neurological and cognitive disorders
- •coagulopathy
- •chronic pain disorders
- •infections at the injection site
- •history of abdominal surgery
结局指标
主要结局
Pain intensity at rest(Hour 2)
时间窗: Hour 2
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest two hours after the surgery.
Pain intensity at rest (Hour 6)
时间窗: Hour 6
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest six hours after the surgery.
Pain intensity at rest (Hour 24)
时间窗: Hour 24
Using the Numeric Rating Scale (NRS) to evaluate the pain intensity at rest 24 hours after the surgery.
次要结局
- The overall dose of remifentanil(During the surgery)