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临床试验/CTRI/2013/09/003968
CTRI/2013/09/003968招募中4 期

Intravenous paracetamol as an adjunct to patient-controlled epidural analgesia with levobupivacaine and fentanyl in labour: a randomized controlled study

Department of anaesthesia and intensive care1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年1月6日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Hourly average consumption of levobupivacaine and fentanyl mixture, including both continuous background infusion plus bolus doses (in ml)

研究概览

简要总结

Labour is reported to be one of the most painful experiences for many women. Epidural analgesia is the most effective treatment available for pain control during labour and delivery, and it is a preferable method because it can provide more effective pain relief compared with other form of pharmacological analgesia. .The review of literature in the area of labour analgesia indicates that significant progress has been made with the advent of PCEA using a combination of low-concentration long-acting local anaesthetics (bupivacaine, levobupivacaine) and low-dose lipid soluble potent opioids (e.g., fentanyl). However, there is still scope of further improving the scenario by studying whether addition of a long-established safe and well-tolerated analgesic like paracetamol by the intravenous route to the intrapartum labour analgesia regime as above can reduce the total hourly consumption of the anaesthetic-opioid combination by the epidural route. If demonstrated to have PCEA drug-sparing effect, then this new regime could enhance the safety of the entire procedure for both mother and child without compromising analgesic efficacy.Therefore the aim of present study is to evaluate the efficacy of intravenous infusion of 1000 mg of paracetamol as an adjunct and its sparing effect on total consumption of levobupivacaine and fentanyl combination given as patient controlled epidural analgesia in labouring parturients

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • •American Society of Anesthesiologists (ASA) grade I and II •Age >18 years •Primigravida •Single gestation •Cephalic presentation at ≥ 36 wk of gestation •In early spontaneous labour (cervical dilation ≤ 5 cm) •Baseline pain score > 30 (on a 0-100 VAS) •Able to use PCEA pump •Requesting epidural analgesia for labour.

排除标准

  • •Refusal by parturient •Parturients who had received parenteral opioids in the last 4 hours •Systemic and local sepsis •Deranged coagulation profile •Parturients having multiple pregnancies and premature labour •Obstetric complications (e.g., premature rupture of amniotic membranes) •Noncephalic presentations •Allergy to study drugs, i.e., paracetamol, levobupivacaine and fentanyl.

结局指标

主要结局

Hourly average consumption of levobupivacaine and fentanyl mixture, including both continuous background infusion plus bolus doses (in ml)

时间窗: starting from 1 hour after administration of paracetamol or saline, till delivery.

次要结局

  • Maternal satisfaction (VAS)(Pain score (VAS))

研究者

发起方
Department of anaesthesia and intensive care
申办方类型
Government medical college

研究点 (1)

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