Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Quality of Recovery - 40 score on discharge
研究概览
简要总结
There has been very little investigation into the management of pain from 2nd trimester termination of pregnancy or unexpected fetal loss. The standard of practice in North America is usually intravenous patient controlled analgesia (IV PCA), using a narcotic wuch as fentanyl. The goal of this study is to compare the quality of recovery after termination of pregnancy using fentanyl IV PCA or patient controlled epidural analgesia (PCEA), a standard of care for live births. The study will be conducted as a randomized controlled trial.
详细描述
Epidural analgesia is known to provide superior analgesia for labour with minimal maternal and fetal side effects. This mode of analgesia is not usually offered to patients who require termination of their pregnancies or who suffer unexpected fetal losses, although they go through labour and delivery with likely more difficult psychological circumstances.
We plan to compare patient controlled epidural analgesia (PCEA) with intravenous patient controlled analgesia (IV PCA), for 2nd trimester terminations of pregnancy. We hypothesize that PCEA provides better quality of recovery than IV PCA. The previously validated Quality of Recovery - 40 questionnaire will be used to measure a patient's quality of recovery. The results of this study will determine the optimal method of pain relief for late termination of pregnancy or fetal loss.
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
- None
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •interruption of pregnancy between 12 and 23 6/7 weeks
排除标准
- •documented allergy to fentanyl or bupivacaine
- •coagulopathy
- •drug or narcotic abuse
- •contraindication to neuraxial analgesia
- •inability to comply with IVPCA or PCEA
- •inability to complete the QoR-40 questionnaire
- •TOP due to maternal problems
研究组 & 干预措施
Epidural (PCEA)
bupivacaine, fentanyl
干预措施: bupivacaine, fentanyl (Drug)
IV PCA
Intravenous fentanyl patient controlled analgesia
干预措施: fentanyl (Drug)
结局指标
主要结局
Quality of Recovery - 40 score on discharge
时间窗: up to 5 days
The primary outcome of this study will be the difference between IV PCA and PCEA groups in aggregate score of Quality of Recovery - 40 on discharge from hospital.
次要结局
- Duration of procedure(24 hours)
- Pain score(24 hours)
- Narcotic-related complications(24 hours)
- Epidural-related complications(24 hours)
- Surgical intervention(24 hours)