A Comparison Between 2 Methods of Local Anesthetic Administration for Maintaining Labor Analgesia After Dural Puncture Epidural
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total local anesthetic and opioid administration
研究概览
简要总结
Intermittent epidural bolus technique opens a new era of interest for maintaining labor anlagesia. The study examines programmed intermittent epidural bolus technique on a scheduled basis to provider-administered bolus anlgesia on patient request, after a dural puncture epidural technique.
详细描述
After dural puncture, an epidural catheter will be placed on nulliparous women between 38 and 40 weeks of gestation presenting for labor . All will receive an test dose of 3ml lidocaine 2%, for properly checking the catheter placement and then an initial dose of 10ml ropivacaine 0,2% with 2 mcg/ml fentanyl. After that, women will be randomly assigned on two groups. Both groups will be receiving the same dose of analgesia (10ml ropivacaine 0,2% plus 1,5 mcg/ml fentanyl. However, one group will be receiving them on scheduled time intervals as programmed intermittent boluses every 60minutes and the other only on patient request for pain relief.
Pain scores, satisfaction, time for adequate analgesia, bromage scores,apgar scores, fetal arterial blood gases, time for delivery and type of delivery will be studied
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nulliparous women
- •38th week of gestation
排除标准
- •patient refusal to have an epidural
- •patient refusal to participate
- •contraindication for epidural
- •neurologic deficit/impairment
- •allergy on local anesthetic chronic pain syndromes
研究组 & 干预措施
Programmed intermittent Bolus Epidural technique
10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered every 60 minutes via an epidural catheter placed for labor analgesia on L2-L3/L3-L4 level
干预措施: Programmed intermittent bolus epidural (Procedure)
Provider administered bolus epidural technique on patient request
10ml ropivacaine 0,2% and 1,5 mcg/ml fentanyl, will be administered by the provider on patient request
干预措施: Provider administered analgesia on patient request (Procedure)
结局指标
主要结局
Total local anesthetic and opioid administration
时间窗: 24hours
the total mg of local anesthetic and opioid consumed via the epidural catheter until the neonate delivery
次要结局
- time needed for delivery(24hours)
- apgar score(24hours)
- type of delivery(24hours)
- Bromage score(24hours)
- Pain score(NRS scale)(24hours)
- total patient satisfaction(24hours)
- neonatal arterial blood gases(24hours)
- time for sucessful level of analgesia(24hours)
研究者
Polyxeni Theodosopoulou
Resident anesthesiologist
Aretaieio Hospital