Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Preincisional Local Field Block for Perioperative Analgesia in Lumbar Spine Surgeries; Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- duration of postoperative analgesia
研究概览
简要总结
Major lumbar spine surgeries are associated with significant postoperative pain that may last for days,So In this study, we intend to evaluate if preventive analgesia with a single injection dose of ultrasound guided bilateral erector spinae is a safe and better method of peri-operative analgesia for lumbar spine surgeries than preincisional local field block.
详细描述
Patients scheduled for lumbar spine surgery will be recruited and a written informed consent will be obtained from patients.
All patients will be assessed clinically and investigated for exclusion of any of the above mentioned contraindications. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) , liver function tests and kidney function tests .
● Operating Room preparation & Equipment: The ultrasound used will be curvilinear high-frequency ultrasound transducer (Siemens acuson x300 3-5 MHz ultrasound)
• Methods: General anaesthesia will be induced. 1.5 μg/kg fentanyl based on lean body weight with maximum dose of 200 μg and 2 mg/kg propofol will be given based on total body weight. Tracheal intubation will be facilitated with 0.5 mg/kg atracurium based on ideal body weight.
Volume controlled ventilation will be adjusted to maintain normocapnia . Anesthesia will be maintained by using 1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.
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
- Double (Participant, 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
- •Patients 18-65 years old.
- •Patients undergoing Lumbar spine surgery (L1-L5).
- •American society of anesthesiologists classification (ASA) I and II.
- •BMI < 35
- •Duration of surgery less than 3 hours
排除标准
- •Patient's refusal.
- •Bleeding disorders (platelets count < 150,000; INR >1.5; PC< 60%) and coagulopathies.
- •Skin lesion, wounds or infection at the injection site.
- •Known allergy to local anesthetic drugs.
- •Chronic opioid users.
- •Patients with pre-operative opioid consumption.
- •Patients on long term therapy of Corticosteroids
结局指标
主要结局
duration of postoperative analgesia
时间窗: 24 hours
Time to first analgesic request
次要结局
- patient satisfaction with anesthesia(24 hours)
- surgeon satisfaction for surgical field accessibility(2 hours)
- cumulative 24 hour opioid consumption(24 hours)
- pain assessment using VAS score at 15minutes, 30 minutes,1,2,4,8,12,24 hours postoperative(24 hours)
- presence of any complications(evey 10 minutes intraoperative till end of surgery (up to 2 hours))
研究者
Abd elmoneim Adel Abd elmoneim
clinical professor
Cairo University