Onset of Labor Epidural Analgesia With Low Dose Bupivacaine and Different Doses of Fentanyl: a Randomized Double Blinded Clinical Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The time, in minutes, since completion of epidural bolus to the first painless contraction
研究概览
简要总结
Epidural analgesia is the most effective form of labor pain relief. Low doses of local anesthetic (freezing solutions) in combination with opioids (narcotics) are commonly used as epidural solutions to provide pain relief. Low dose local anesthetic solutions with opioids for labor have been shown to decrease motor block (leg weakness or temporary paralysis), without affecting labor pain relief. However, onset of pain relief can be delayed with these low dose solutions. The standard epidural solution used at Victoria Hospital is a low dose of local anesthetic called bupivacaine mixed with fentanyl, an opioid, for labor epidural pain relief.
There is some evidence that the addition of more fentanyl to the epidural bolus dose of bupivacaine at the start of labor epidural analgesia can speed onset of pain relief. Both medications are safe for you and your baby.
This study will investigate whether the addition of different doses of fentanyl (20 mcg, 50 mcg and 100 mcg) to the epidural bolus dose speeds onset of pain relief.
The study hypothesis is that the onset of epidural labor analgesia will be shortest with the larger fentanyl epidural bolus.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1 or 2
- •Pregnant women in early labor (cervical dilation <5cm)
- •Singleton fetuses
- •Gestational age more than 36 weeks
- •Normal fetal heart rate tracing
排除标准
- •Severe pre-ecclampsia
- •Antepartum hemorrhage
- •Chronic pain
- •Substance abuse
- •Language barrier between patient and investigator
- •Contraindications to epidural analgesia
- •Allergies to local anesthetics or fentanyl
- •Morbid obesity
- •Previous administration of opioid analgesia
研究组 & 干预措施
F20
Patients randomized to this arm of the study receive 20 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose
干预措施: Fentanyl (Drug)
F50
Patients randomized to this arm of the study receive 50 mcg fentanyl with 8 mg bupivacaine as their epidural loading dose
干预措施: Fentanyl (Drug)
F100
Patients randomized to this arm of the study receive 100 mcg fentanyl and 8 mg bupivacaine as their epidural loading dose
干预措施: Fentanyl (Drug)
结局指标
主要结局
The time, in minutes, since completion of epidural bolus to the first painless contraction
时间窗: Time since epidural bolus dose administration (At 1 and 5 minutes )
A painless contraction = verbal Numeric Pain Rating Scale less than or equal to 3/10
次要结局
- Sensory block height to ice(30 minutes after epidural bolus dose)
- Time, in minutes, from epidural bolus dose to use of patient controlled epidural demand dose(Estimated time frame 1 hour)
- Breastfeeding(24 hours after delivery)
- Pruritis(30 minutes after epidural bolus dose)
- Nausea(30 minutes after epidural bolus dose)
- Maternal sedation(30 minutes after epidural bolus dose)
- Hypotension(30 minutes after epidural bolus dose)
- Motor block(30 minutes after epidural bolus dose)
- Patient satisfaction of analgesia(30 minutes from epidural bolus dose)
- Incidence of failed analgesia(30 minutes after epidural bolus dose)
- Incidence of fetal bradycardia(Estimated time frame 24 hours)
- Neonatal Apgar scores(At 1 and 5 minutes post-delivery)
- Time, in minutes, from completion of epidural test dose to delivery(Estimated time frame 24 hours)
- Type of delivery(Estimated time frame 24 hours)
- Fetal birth weight(Estimated time frame 24 hours)
研究者
Indu Singh
Associate Professor
Lawson Health Research Institute