Programmed Intermittent Epidural Bolus Interval 90 Min of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- adequate labour analgesia
研究概览
简要总结
Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). The advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.The theory behind PIEB is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.Different approaches using different timings and volumes for PIEB have been proposed to achieve the optimal regimen. Many studies showed evidence that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 μg/mL delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (EI90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients of ASA physical status 2-3 with a singleton pregnancy
- •gestational age > 37 weeks
- •regular uterine contractions occurring at least every 5 min;
- •cervical dilation 2-5 cm
- •pain > 5 (Visual analogue score (VAS) 0-10) at the time of request for epidural analgesia .
排除标准
- •Refusal to concent
- •Contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaine or fentanyl
- •Patients who had opioids or sedatives within 4 h preceding epidural insertion.
- •Unintentional dural puncture.
- •Patient who deliver within 1 h after initiation of epidural clinician bolus.
- •The inability to achieve as VAS score ≤2 after the initial loading dose will be considered as a failure and will be excluded from the study.
研究组 & 干预措施
Nulliparous
Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5
干预措施: programed intermittent epidural bolus interval 90 (EI90) (Device)
Multiparous
Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5
干预措施: programed intermittent epidural bolus interval 90 (EI90) (Device)
结局指标
主要结局
adequate labour analgesia
时间窗: six hours
Time of first call for bolus dose of epidural After loading dose
次要结局
- Upper sensory block(24hours)
- Side effects(24 hours)
- Motor block(24 hours)
- Total anaesthetic volume(24 hours)
- Visual Analogue Scale to pain(24 hours)
研究者
rabab Mohammad habeeb
Principal investigator
Menoufia University