Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Pain scorings
研究概览
简要总结
It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Nulliparas
- •Request epidural analgesia
排除标准
- •Allergic to opioid or local anesthetics
- •Fail to perform epidural puncture and catheterization
- •Organ dysfunction
- •Contraindications for epidural anesthesia
研究组 & 干预措施
Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
干预措施: Sole local anesthetic (Drug)
Sole local anesthetic
Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently
干预措施: Ropivacaine (Drug)
Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
干预措施: Sufentanil (Opioid plus local anesthetic) (Drug)
Opioid plus local anesthetic
Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain scorings
时间窗: up to 3 days
Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.
次要结局
- Dizziness(From post-randomization to post-delivery day 3)
- Sedation(From post-randomization to post-delivery day 3)
- Respiratory depression(From post-randomization to post-delivery day 3)
- Pruritus(From post-randomization to post-delivery day 3)
- Nausea(From post-randomization to post-delivery day 3)
- Psychological effects(From post-randomization to post-delivery day 3)
- Myoclonus(From post-randomization to post-delivery day 3)
- Maternal heart rate(From post-randomization to post-delivery day 3)
- Miosis(From post-randomization to post-delivery day 3)
- Cesarean section(The time at the end of the labor delivery)
- Vomiting(From post-randomization to post-delivery day 3)
- Drowsiness(From post-randomization to post-delivery day 3)
研究者
Fu Zhou Wang
Dr
Nanjing Medical University