Efficacy of oral paracetamol for sparing the dosage of levobupivacaine-fentanyl combination in patient-controlled combined spinal-epidural analgesia in labouring parturients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hourly total consumption of levobupivacaine + fentanyl mixture, including both continous background infusion plus bolus doses(in ml) starting from 1 hour after ingestion of paracetamol or placebo, for duration of labour
研究概览
简要总结
Labour pain is the frequently described as the most severe pain that a woman will experience during her lifetime. Neuraxial analgesia is the only technique that can completely relieve the pain of labour and is gold standard for labour analgesia. One of the most popular and effficient method of pain relief is the epidural analgesia tenchnique done by placing a catheter in epidural space. A better option from among the preferred epidural anaesthesia is the use of patient controlled epidural analgesia(PCEA) for labour and delivery. Combined spinal-epidural(CSE) analgesia has become widely popular alternative to low dose epidural analgesia for labour. Low concentrations of bupivacaine provide excellent analgesia without significant motor block. Levobupivacaine has been increasingly used because of its safer pharmacological profile. Use of fentanyl in labour analgesia is not associated with side effects like drowsiness, nausea, respiratory depression in neonates reported in use of other systemic opiods as pethidine, tramadol, remifentanyl. Injection paracetamol has been used as an adjunct to analegsia in number of studies in different surgical settings. However there is only one study of intravenous paracetamol used as an adjunct to intrapartum analgesia drug. It has been seen that overall bioavailability of oral paracetamol is equivalent to intravenous paracetamol. Therefore the aim of the present study is the evaluate the efficacy of oral paracetamol as an adjunct and dose sparing effect on total consumption of levobupivacaine and fentanyl combination in labouring parturients using PCEA.
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 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •ASA Grade 1 and 2 2)Age more than 18 years 3)Primigravida Single gestation 4)Cephalic presentation at 36 completed weeks of gestation 5)In early spontaneous labour(cervical dilatation < 5cm) 6)Baseline pain score > 30(on a 0-100 VAS) 7)Able to use PCEA pump 8)Requesting epidural analgesia for labour.
排除标准
- •Refusal by parturient 2)Parturients who had received parenteral opiods in the last 4 hours 3)Systemic and local sepsis 4)Deranged coagulation profile 5)Parturients having multiple pregnancies and premature labour 6)Obstetrics complications(eg.
- •PROM) Chorioamnionitis 7)Patients with hepatic and renal impairment 8)Unable to swallow oral tablets 9)HELLP syndrome 10)Noncephalic presentations 11)Allgery to study drugs i.e levobupivacaine,fentanyl,paracetamol.
结局指标
主要结局
Hourly total consumption of levobupivacaine + fentanyl mixture, including both continous background infusion plus bolus doses(in ml) starting from 1 hour after ingestion of paracetamol or placebo, for duration of labour
时间窗: Till delivery of baby
次要结局
- Maternal satisfaction(VAS)(Pain score(VAS))
