Comparison of the Efficacy of One Level and Two Level of Bilateral Thoracic Erector Spinae Plane Block Combined With General Anesthesia in Laparoscopic Bariatric Surgery for Obese Patients: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • visual analog scale (VAS) scores during first 24 hour postoperative
研究概览
简要总结
comparison of the feasibility and efficacy of the one-level and two-level thoracic ESP block and their effect on intraoperative and postoperative analgesia in bariatric surgeries.
详细描述
Following approval from Ethics and Research Committee of Anaesthesia Department, Faculty of Medicine, Cairo University; 70 patients fulfilling inclusion criteria will be included in this randomized prospective comparative trial.
A.preoperative:
History will be taken from all patients. Age and then American Society Anaesthesiologists' (ASA) score will be recorded.
Preoperatively patients' laboratory investigations as complete blood picture, coagulation profile, liver and renal functions will be recorded. General examination will be carried out with examination of the back to exclude infection at the injection site and anatomical deformities.
Baseline vital signs will be recorded including non-invasive measurement of systolic, mean, diastolic arterial pressures, and HR and oxygen saturation. After inserting an intravenous (IV) access, the patient will be pre-medicated with metoclopramide in a dose 0.1-0.2 mg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patient age ranges 18 to 60 years old
- •Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2
- •American Society of Anesthesiologists (ASA) physical status classes II to III
- •Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries
排除标准
- •• Refusal of regional block
- •Patients with neurological, psychological disorders or those lacking cooperation
- •Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea
- •Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- •Patients with bleeding disorders defined as (INR >1.4) and/ or (platelet count <100,000/µL)
- •Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
- •Patients who are allergic to amide local anesthetics.
研究组 & 干预措施
two levels of bilateral thoracic erector spinae plane block
two level of bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric Surgery for obese patients
干预措施: bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric surgery in obese patients (Procedure)
one level of bilateral thoracic erector spinae plane block
one level of bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric Surgery for obese patients
干预措施: bilateral thoracic erector spinae plane block combined with general anesthesia in laparoscopic bariatric surgery in obese patients (Procedure)
结局指标
主要结局
• visual analog scale (VAS) scores during first 24 hour postoperative
时间窗: post-operative period at 1 h (hour) , 2 h, 4 h, 8h, 12h,18h and 24 h (hours).
Pain will be classified as mild (VAS 1-3), moderate (VAS 4-6), and severe (VAS 7-10) .
次要结局
未报告次要终点
研究者
Emad Mohamed Ahmed Abdelhafez
lecturer
Kasr El Aini Hospital