Comparison of erector spinae plane block and transversus abdominis plane block with dexmedetomidine as adjuvant for post operative analgesia after caesarean section under spinal anaesthesia.
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Vardhman Mahavir Medical College and Safdarjung Hospital
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the analgesic efficacy of erector spinae plane block and transversus abdominis plane block with dexmedetomidine as adjuvant for post op analgesia after caesarean section under spinal anaesthesia by assessing the time for first rescue analgesia.
概览
简要总结
This study is a prospective interventional randomised comparative study to compare erector spinae plane block with transversus abdominis plane block with dexmedetomidine as an adjuvant for post operative analgesia after caesarean section under spinal anaesthesia with the hypothesis that the use of erector spinae plane block is comparable to transversus abdominis plane block with dexmedetomidine as adjuvant for post operative analgesia for caesarean section under spinal anaesthesia.Primary objective is to compare the analgesic efficacy of erector spinae plane block and transversus abdominis plane block with dexmedetomidine as adjuvant for post op analgesia after caesarean section under spinal anaesthesia by assessing the time for first rescue analgesia.Secondary objectives are visual analogue scale (resting and dynamic) will be assessed at rest and on movement at intervals of 6 hourly till 24 hours and the 12 hourly till 48 hours. (0,6,12,24,36,48 hours),total tramadol consumption for 48 hours ,adverse effects if any like hypotension, bradycardia, sedation,severity of pain interference with performance of activities of daily living (ADL) breastfeeding, and general care (cleaning, changing, comforting) of the infant. ADLs assessed will include include changing position in bed, standing and walking, and eatingpatient’s overall satisfaction score at discharge using 0-5 score (0 = worst ,1= very bad, 2 = bad, 3 = good, 4 = very good, 5 = best).The sample size studied would be 80, ie, 40 per group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •American Society of Anaesthesiologists physical status II, or III normal singleton pregnancy (with a gestational age of at minimum 37 weeks) undergoing caesarean section under spinal anaesthesia.
排除标准
- •Any contraindication to spinal anaesthesia (systemic coagulopathy, anatomic abnormalities, localized infection), known allergy to study medication, inability to comprehend or participate in pain scoring system.
结局指标
主要结局
To compare the analgesic efficacy of erector spinae plane block and transversus abdominis plane block with dexmedetomidine as adjuvant for post op analgesia after caesarean section under spinal anaesthesia by assessing the time for first rescue analgesia.
时间窗: Patients will be followed up at baseline,6 hours, 12 hours, 24 hours,36 hours, and 48 hours.
次要结局
- 1.Visual analogue scale (resting & dynamic) will be assessed at rest & on movement at(intervals of 6 hourly till 24 hours & the 12 hourly till 48 hours. (0,6,12,24,36,48 hours).)
- 2.Total tramadol consumption for 48 hours(Calculated at the end of 48 hours.)
- 3.Adverse effects if any like hypotension, bradycardia, sedation.(Patients will be followed up at baseline,6 hours, 12 hours, 24 hours,36 hours, & 48 hours.)
- 4.Severity of pain interference with performance of activities of daily living (ADL) breastfeeding, & general care (cleaning, changing, comforting) of the infant. ADLs assessed will include include changing position in bed, standing & walking, & eating(Patients will be followed up at baseline,6 hours, 12 hours, 24 hours,36 hours, & 48 hours.)
- 5.Patient’s overall satisfaction score at discharge using 0-5 score (0 = worst ,1= very bad, 2 = bad, 3 = good, 4 = very good, 5 = best).(Assessed at time of discharge.)
研究者
Sahla Parveen
VMMC and Safdarjung Hospital