Comparison of Thoracic Epidural and Erector Spinae Plane block for analgesia following multiple rib fractures: A Randomized open label trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess analgesia by VAS score in post procedure period for 96 hours
研究概览
简要总结
Patients will be randomly allocated into two groups in 1:1 allocation ratio using computer-generated random numbers. Simple random sequence will be generated from the computer. The group allocation numbers will be concealed in sealed opaque envelopes that will be opened just before the performance of block. Group1 patients will receive TE, whereas Group 2 patients will receive ESP block on the affected side.
In the procedure room, routine monitoring including continuous electrocardiography (ECG), non-invasive blood pressure (NIBP) and peripheral oxygen saturation (SpO2) will be attached and baseline vitals will be recorded. All the patients will receive premedication with intravenous (IV) fentanyl 1µg/kg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •having multiple rib fractures (2 or more ribs) with VAS score more than 4.
排除标准
- •1.Patient refusal 2.Unconscious patients 3.Open wound/ Pre-existing infection at the site of needle insertion 4.Coagulation Disorders 5.Bilateral rib fractures 6.Severe traumatic brain /spinal cord injury 7.Patient who are intubated /on mechanical ventilation 8.Patient with shock 9.History of abdominal organ injury 10.Patients with renal disorders 11.History of psychiatric illness and pre-existing neurological deficits 12.Known allergy to study drugs.
结局指标
主要结局
To assess analgesia by VAS score in post procedure period for 96 hours
时间窗: 96 hours
次要结局
- The secondary outcome will be to assess and compare(Inspiratory capacity(IC) by Coach’s Spirometer)