Epidural Analgesia for Labor Pain and Infant Neurobehavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
研究概览
简要总结
Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.
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
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18years and <45years
- •Spontaneous labor
- •Analgesia request
排除标准
- •Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
- •Participants younger than 18 years or older than 45 years
- •Those who were not willing to or could not finish the whole study at any time
- •Using or used in the past 14 days of the monoamine oxidase inhibitors
- •Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
- •Subjects with a nonvertex presentation or scheduled induction of labor
研究组 & 干预措施
Local anesthetic plus opioid 1
Local anesthetic (ropivacaine 0.125%) plus first opioid dose (sufentanil 0.3 microgram/ml) delivered peridural space
干预措施: Ropivacaine and sufentanil (Drug)
Local anesthetic plus opioid 2
Local anesthetic (ropivacaine 0.125%) plus second opioid dose (sufentanil 0.4 microgram/ml) delivered peridural space
干预措施: Ropivacaine and sufentanil (Drug)
Local anesthetic plus opioid 3
Local anesthetic (ropivacaine 0.125%) plus third opioid dose (sufentanil 0.5 microgram/ml) delivered peridural space
干预措施: Ropivacaine and sufentanil (Drug)
Local anesthetic 1 plus opioid
First local anesthetic dose (ropivacaine 0.0625%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
干预措施: Ropivacaine and sufentanil (Drug)
Local anesthetic 2 plus opioid
Second local anesthetic dose (ropivacaine 0.1875%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
干预措施: Ropivacaine and sufentanil (Drug)
Local anesthetic 3 plus opioid
Third local anesthetic dose (ropivacaine 0.25%) plus opioid (sufentanil 0.4 microgram/ml) delivered peridural space
干预措施: Ropivacaine and sufentanil (Drug)
结局指标
主要结局
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
时间窗: Immediate after birth (0 min)
次要结局
- Apgar scoring(One min and 5min after birth.)
- Umbilical-cord gases analysis(At the time baby was born (0min))
- Neonatal sepsis evaluation(One hour after the baby was born)
- Neonatal antibiotic treatment(One hour after the baby was born)
- Incidence of maternal side effects(Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women))
- Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)(1wk after birth)