Comparison of Programmed Intermittent Epidural Bolus With Continuous Epidural Infusion for Labor Epidural Analgesia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Maternal visual analogue scale (VAS)
研究概览
简要总结
Sixteen million babies were born in 2010, approximately half were by cesarean. Labor analgesia should be the first choice for these parturients based on the consideration of security and humanization. However this labor analgesia rate is quite low in China (<5%) while in western country, this rate is up to 60%. Programmed intermittent epidural bolus (PIEB) is the latest technique for labor analgesia which has less neurotoxicity theoretically compared with Continuous Epidural Infusion(CEI) with Patient controlled epidural analgesia (PCEA) which is used most commonly. In that study, they reported less total local anesthetic consumption, fewer manual bolus doses and greater patient satisfaction with the PIEB technique. In China, multiple factors contribute to the reasons of low labor analgesia rate. From the patient's point of view, worrying about unsatisfied analgesia, and not adapted to the symptoms of motor block, such as inability to move their legs distressing, both are important reasons of refusing labor analgesia and preferring to cesarean delivery. Therefore, in this clinical trial, we plan to find a safer and more effective regimen for labor analgesia in Chineseparturients. This clinical trial is designed to prove PIEB used Ropivacaine is safer and more effective than CEI for labor analgesia in Chinese parturients.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who agree to join this study
- •Age: 22y-40y
- •American Society of Anesthesiologists (ASA) physical status 1 or 2
- •Gestation : 37-41 weeks
- •Primipara
- •Singleton fetus and head presentation
- •In early labor: cervical dilation for 1-3cm
- •Requesting labor epidural analgesia
排除标准
- •Contraindication for epidural analgesia
- •Height less than 150 cm or more than 170 cm
- •Morbid obesity (BMI more than 35)
- •High-risk pregnancy:(gestational diabetes mellitus, gestational hypertension, placenta previa, placental abruption, preeclampsia)
- •Received parenteral opioids
- •Unable to perform motor block evaluation tests
研究组 & 干预措施
PIEB 1
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose
干预措施: sufentanil (Drug)
CEI
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose
干预措施: Epidural analgesia (Procedure)
CEI
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose
干预措施: Continuous epidural infusion (Procedure)
CEI
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose
干预措施: ropivacaine (Drug)
CEI
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of CEI: 10 ml/h, beginning immediately after the initial dose
干预措施: sufentanil (Drug)
PIEB 1
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose
干预措施: Epidural analgesia (Procedure)
PIEB 1
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose
干预措施: Intermittent epidural bolus (Procedure)
PIEB 1
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil.The basal infusion of PIEB1: 5 ml per 30 min, beginning 30 min after the initial dose
干预措施: ropivacaine (Drug)
PIEB 2
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose
干预措施: Epidural analgesia (Procedure)
PIEB 2
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose
干预措施: Intermittent epidural bolus (Procedure)
PIEB 2
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose
干预措施: ropivacaine (Drug)
PIEB 2
Initial loading dose:10 ml (0.125% ropivacaine with 0.4 μg/ml sufentanil) Epidural infusion with maintain dose: 0.08% ropivacaine with 0.4 μg/ml sufentanil. The basal infusion of PIEB2: 10 ml per 60 min, beginning 60 min after the initial dose
干预措施: sufentanil (Drug)
结局指标
主要结局
Maternal visual analogue scale (VAS)
时间窗: At time of initiation of analgesia and hourly thereafter until 1 hours postpartum (approximately 10 hours)
a visual analog scale (VAS) with a 10 cm vertical score ranged from "no pain" to "worst possible pain"
次要结局
- Neonatal weight(At delivery)
- Mean number of PCEA(At two hours postpartum)
- Maternal respiratory rate(At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours))
- Maternal blood pressure(At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours))
- Maternal modified Bromage scale(At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours))
- Subject's Satisfaction with labor epidural analgesia(At the time after childbirth)
- Total ropivacaine and sufentanil consumption(At two hours postpartum)
- Proportion of parturients requiring additional PCEA boluses(At two hours postpartum)
- Rate of "very satisfied"and/or "satisfied",Proportion of subjects who has experienced Visual analog scale (VAS) score for pain more than 3 scale(At two hours postpartum)
- Maternal heart rate(At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours))
- Rates of cesarean delivery and instrument-assisted delivery(At time of placental delivery)
- Duration of analgesia(Initiation of analgesia to 2 h postpartum (approximately 10 hours))
- Durations of labor stages(From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours))
- Use of oxytocin after analgesia(At twenty-four hours postpartum)
- Incidence of maternal side effects(Initiation of analgesia to 2 hour postpartum (approximately 10 hours))
- Neonatal Apgar scale(At the first and fifth minutes after baby was born)
- Fetal heart rate(From initiation of analgesia to delivery (approximately 8 hours))
研究者
Caijuan Li
Nanjing Maternity and Child Health Care Hospital
Nanjing Maternity and Child Health Care Hospital