Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Maternal Visual Analog Scale (VAS) rating of pain
研究概览
简要总结
Labor analgesia is an essential health caring procedure for women. However, epidural analgesia cannot be performed on all subjects for different contraindications, such as lower platelet counter, back infection at the puncture site, and fear of epidural injection etc. Therefore, intravenous analgesia is an alternative for such conditions. Given the influence of intravenous administration of drugs on fetus, the drug selection is very important. Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection, which is similar in both maternal and fetal environment. Thus the fetus-associated side effects would be less than other drugs. The investigators hypothesized that remifentanil would be a superior intravenous drug used with patient-controlled technique for labor analgesia.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women
- •> 18 years and < 45 years
- •Spontaneous labor
- •Analgesia request
- •Epidural puncture contraindications
- •Tendency of bleeding
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
- •Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization
- •Diagnosed diabetes mellitus and pregnancy-induced hypertension
- •Twin gestation and breech presentation
研究组 & 干预措施
1
Intravenous administration of hydromorphone intermittently
干预措施: Hydromorphone (Drug)
2
Remifentanil intravenous patient-controlled analgesia
干预措施: Remifentanil (Drug)
结局指标
主要结局
Maternal Visual Analog Scale (VAS) rating of pain
时间窗: Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery
次要结局
- Rate of cesarean delivery(Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals))
- Rate of instrument-assisted delivery(Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals))
- Indications of cesarean delivery(Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals))
- Duration of analgesia(Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals))
- Maternal satisfaction with analgesia(At the end of the vaginal delivery (this time period underwent changing in different individuals))
- Maternal oral temperature(Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals))
- Use of oxytocin after analgesia(Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals))
- Maximal oxytocin dose(At the end of vaginal delivery (this time period underwent changing in different individuals))
- Breastfeeding success at 6 weeks after vaginal delivery(At the sixth week after successful delivery)
- Neonatal one-minute Apgar scale(At the first minute of baby was born)
- Neonatal five-minute Apgar scale(At the fifth minute of baby was born)
- Umbilical-cord gases analysis(At the time baby was born (0 min))
- Neonatal sepsis evaluation(After the baby was born (15 min after delivery))
- Neonatal antibiotic treatment(After the baby was born (one day after delivery))
- Incidence of maternal side effects(Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals))