Efficacy of the ultrasound guided Lumbosacral Erector spinae plane block for labour analgesia: An exploratory single arm study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Score (NRS)
研究概览
简要总结
This is a single arm exploratory study to study efficacy of lumbosacral erector spinae plane block for labour analgesia. After taking informed written consent, patient will be shifted in OT and placed in left lateral position. Under USG guidance, lumbosacral ESP block will be given( 80 ml 0.125 percent Bupivacaine)with Dexamethasone 8mg and catheter will be placed so that tip lies at S2-S4 level. We will assess pain score as primary objective using Numerical Rating Scale at every 30 min and then every 1hour till 6 hour post delivery. We will assess Heart Rate, Non Invasive Blood Pressure at every 30 min and then every 1 hour till 6 hour post delivery. Motor blockage will be assessed using Modified Bromage score every 15 min during first hour then every 1 hour till 6 hour post delivery. .Outcome of labour will be noted and neonate APGAR score at 1 and 5 min will be seen. If NRS is more than 4, rescue analgesia( 20 ml 0.125 percent Bupivacaine) and inj. Tramadol will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 ASA grade-I and II 2 Women in labour scheduled for normal vaginal delivery those seeking pain relief 3 Cephalic presentation 4 more than 34week gestation 5 Who are willing to give consent.
排除标准
- •1 ASA grade- III, IV, V 2 Participants unwilling to provide consent 3 Women with Severe pre-eclampsia with coagulopathy (INR more than 1.5, platelet count less than 75,000) 4 Cephalo-pelvic disproportion (CPD) 5 Participants with known history of drug allergy to bupivacaine or dexamethasone.
结局指标
主要结局
Pain Score (NRS)
时间窗: At 30 min and then every 1h till 6h post delivery
次要结局
- Heart Rate
- Non invasive blood pressure(At 30 min and then every 1h till 6h post delivery)
- Motor power in lower limb(At 30 min and then every 1h till 6h post delivery)
- Outcome of labour
- APGAR score(At 1 min and 5 min post delivery)
- Sensory level(at 1 hour after the first bolus)
研究者
Dr Abhishek Gautam
AIIMS Rishikesh