NCT07022600已完成不适用
Erector Spinae Plane Block and Its Impact on Postoperative Diaphragmatic Dysfunction in Morbidly Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy, A Double-blind Randomized Control Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Incidence of diaphragmatic dysfunction in both groups
研究概览
简要总结
postoperative diaphragmatic dysfunction is critical especially in morbidly obese patients
详细描述
Investigators aimed to evaluate the impact of erector spinae plane block on the incidence of postoperative diaphragmatic dysfunction in morbidly obese patients (Body mass index more than or equal 40)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, 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
- •morbidly obese (body mass index> 40)
- •undergoing sleeve gastrectomy
排除标准
- •allergy to bupivacaine
- •respiratory comorbidities
- •preoperative diaphragmatic dysfunction
- •Patient refusal
- •inability to adequately visualize diaphragm
研究组 & 干预措施
erector spinae group
Active Comparator
Patients will receive erector spinae block
干预措施: Diaphragmatic ultrasound (Device)
Control group
Placebo Comparator
Patients will receive bilateral sham ultrasound-guided ESPB
干预措施: Diaphragmatic ultrasound (Device)
结局指标
主要结局
Incidence of diaphragmatic dysfunction in both groups
时间窗: baseline and 2 hours after surgery
postoperative diaphragmatic excursion 10 mm at 2 hours after surgery
次要结局
- Forced expiratory volume at one second(at baseline, 2 and 24 hours postoperatively)
- numeric rating scale(at 24 hours after surgery)
- Forced vital capacity (in Liter)(at baseline, 2 hours, and 24 hours after surgery)
- Peak expiratory flow rate (Liter/sec)(baseline, 2 hours, and 24 hours)
研究者
Mina Adolf Helmy
Lecturer of anesthesia and critical acre
Cairo University
研究点 (2)
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