Epidural Morphine Following Vaginal Delivery: A Randomised, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
研究概览
简要总结
The investigators believe that pain management following a vaginal delivery can be improved. Many women receive epidural medication during labor and delivery, and the investigators felt that using the epidural following delivery might improve the first day pain. This study is to determine whether a single dose of epidural morphine given to mothers after a vaginal delivery will reduce the perineal pain in the postpartum period.
详细描述
Vaginal deliveries comprise 80-85% of all deliveries. Although this is felt to be natural and safe, this route can be associated with significant perineal trauma and subsequent postpartum perineal pain. The degree of perineal trauma varies from the minimum of vaginal stretching and distension associated with labor, to episiotomy and significant perineal tears. In spite of the differences in the degree of injury following vaginal delivery, postpartum pain therapy is poorly organized and at best consists of simple analgesics and anti-inflammatory drugs. The purpose of this study is to determine if a single dose of epidural-administered morphine offers additional advantage to an organized program for the management of immediate postpartum perineal pain following vaginal delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy parturients (ASA 1 or 2) of > 34 weeks gestational age who chose epidural analgesia for labor, and deliver vaginally.
排除标准
- •Women whose labor is terminated by cesarean delivery
- •Parturients with known morphine allergy
- •Parturients with narcotic addiction past / present
研究组 & 干预措施
Epidural Morphine
2.5 mg dose of epidural morphine given within one hour following vaginal delivery
干预措施: Preservative-free epidural morphine (Drug)
Placebo
5 ml of epidural preservative-free saline given within one hour following vaginal delivery
干预措施: Placebo (Drug)
结局指标
主要结局
The Number of Women Who Received Systemic Narcotic Analgesics in the First 24 Hours Postpartum
时间窗: 24 hours postpartum
次要结局
- Time to First Request for Analgesia(Hours)
- Maternal Visual Analogue Scale (VAS) Score at Time of Request for First Additional Analgesic(by 24 hours postpartum)
- Maternal Satisfaction With Perineal Pain Management(at 24 hours postpartum)
- Side Effects(at 24 hours postpartum)