General Anesthesia vs Paravertebral Block With General Anesthesia For Post-Operative Pain Post Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
The incidence of obesity is steadily rising. Laparoscopic sleeve gastrectomy (LSG) is an innovative approach to the surgical management of morbid obesity.
We will be discussing the effect of adding paravertebral block (PVB) in addition to general anesthesia (GA) vs. GA alone for post operative pain after laparoscopic sleeve gastrectomy.
详细描述
This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups: Group 1 will be patients who receive general anesthesia with paravertebral block, whereas group 2 will be patients who receive general anesthesia with placebo block.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with body mass index (BMI) greater than or equal to 30
- •American Society of Anesthesiologist (ASA) score greater than or equal to 2
- •Undergoing laparoscopic gastric sleeve surgeries
排除标准
- •Patients with ASA score less than 2 and greater than 4
- •Patients with any type of allergy to local anesthesia
- •Patients refusing to be part of the study (refusal to sign consent)
- •Any complication during surgery or anesthesia
结局指标
主要结局
postoperative pain
时间窗: within 1 week postoperatively
The primary aim is to compare the effect of paravertebral block with general anesthesia versus general anesthesia alone on postoperative pain after laparoscopic sleeve gastrectomy surgeries. Pain will be assessed using the Visual Analogue scale (VAS) with a score of 0 denoting no pain and 10 maximum possible pain.
次要结局
- ambulation(within 1 week postoperatively)
研究者
Saleh Kanawati
Anesthesiologist
Makassed General Hospital