Ultrasound Guide Bilateral Erector Spinae Block Versus Caudal Epidural Analgesia for Perioperative Analgesia in Lumbar Spine Surgeries:Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- time to first analgesia request
研究概览
简要总结
Major lumbar spine surgeries are associated with severe postoperative pain that usually lasts for at least 3 days.Caudal epidural analgesia has a crucial role in providing effective pain relief post lumbar spine surgeries by blocking sensory input at the level of the spinal cord. Erector Spinae Plane Block (ESPB) as a new technique of trunk fascia block was proposed in 2016Reports showed that ESPB significantly relieved postoperative pain in patients with lumbosacral spine surgery, reducing the use of analgesics.
The aim of this work is to evaluate the pre-emptive analgesic effect of Ultrasound guided bilateral erector spinae block Vs Caudal epidural analgesia in Lumbar spine surgeries during peri-operative period.
Objectives:
- To assess the duration of analgesia in both groups and time to rescue analgesia .
- To assess Visual analogue scale (VAS) score in both groups.
- To assess complications of both groups
详细描述
This is a randomized controlled study designed to include 50 patients aged from 18 to 65 years old undergoing lumbar spine surgeries.
fifty patients meeting the inclusion criteria will be randomly assigned into two equal groups: Group A(n=25): caudal epidural group. Group B(n=25): bilateral ultrasound guided Erector spinae block group.
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 SonoSite M Turbo (USA), the scanning probe will be the linear multi-frequency 6-13 megahertz transducer (L25 x 6-13 MHz linear array).
Methods:
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
- 是
入选标准
- •Patients undergoing Lumbar spine surgery (L1-L5).
- •American society of anesthesiologists classification (ASA) I and II.
排除标准
- •Patient's refusal.
- •Bleeding disorders (platelets count < 150,000; International normalized ratio >1.5; PC< 60%) and coagulopathies.
- •Skin lesion, wounds or infection at the injection site.
- •Known allergy to local anesthetic drugs.
- •Chronic opioid or NSAIDS users.
- •Patients with pre-operative opioid consumption
结局指标
主要结局
time to first analgesia request
时间窗: 12 hours
postoperative first rescue analgesia time
次要结局
- presence of any complications(24 hours)
- Mean arterial blood pressure(evey 10 minutes intraoperative till end of surgery (up to 2 hours))
- cumulative 24 hours opioid consumption(24 hours)
- VAS score(at 15 & 30 mins, then at 2, 6, 12, 24 hours post-operatively)
- Heart rate(every 10 minutes intraoperative till end of surgery(up to 2 hours))
研究者
Abd elmoneim Adel Abd elmoneim
clinical professor
Cairo University