A comparative study on Spinal anesthesia alone versus spinal anesthesia along with Ultra sound guided bilateral erector spinae plane block for post operative analgesia in lower abdominal surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Analgesia will be assessed post operatively using Visual Analogue Scale
研究概览
简要总结
A prospective, randomized parallel arm trial will be undertaken as a comparative study on Spinal anesthesia alone versus spinal anesthesia along with Ultra sound guided bilateral erector spinae plane block for post operative analgesia in lower abdominal surgeries.
All patients will receive spinal anaesthesia, but the test group will receive additional bilateral erector spinae plane block in lateral position under ultrasound guidance immediately after operation. To achieve adequate ESP block, 20ml of levobupivacaine (0.25%) will be injected in each side.
The primary outcome is to assess analgesia post operatively using Visual Analogue Scale (0 - no pain and 10 - worst pain) at 30 mins, 1 hour, 3 hours, 6 hours, 12 hours, 18 hours and 24 hours. The secondary outcomes to be studied are hemodynamic parameters i.e. Pulse Rate, Systolic BP, Diastolic BP, Mean Arterial Pressure at similar time point.
The study site is Tezpur Medical College and Hospital, Assam and study duration is 1 year. The sample size assuming level of significance alpha 0.05 and power of study 0.8, is calculated to be 70.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 to 70 years Body weight 50kg to 75 kg BMI more than 18.5 to less than 25 American Society of Anaesthesiology Physical Status I and II Scheduled for elective lower abdominal surgeries under spinal anaesthesia Lower abdominal surgeries which will be done making incision such as infraumbilical midline or paramedian incision, pfannenstiel incision, bilateral oblique incision over inguinal region.
排除标准
- •Patient refusal to participate Patients requiring emergency surgery Patients having remarkable history of cardiovascular, metabolic or psychological disorder Pregnant patient or lactating mother Patient having known coagulopathy or patient on anticoagulation therapy Patient having infection at site of injection.
结局指标
主要结局
Analgesia will be assessed post operatively using Visual Analogue Scale
时间窗: 30 mins | 1 hour | 3 hours | 6 hours | 12 hours | 18 hours | 24 hours
次要结局
- Hemodynamic parameters i.e. Pulse Rate, Systolic BP, Diastolic BP, Mean Arterial Pressure(30 mins)
研究者
Alatfuddin Ahmed
Tezpur medical college and hospital, Assam