Analgesia for 2nd Trimester Termination of Pregnancy
Analgesia for 2nd Trimester Termination of Pregnancy: a Randomized Controlled Trial of Intravenous Versus Epidural Patient Controlled Analgesia
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5G1X5
- Mount Sinai Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- interruption of pregnancy between 12 and 23 6/7 weeks
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Epidural (PCEA)
bupivacaine, fentanyl
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10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
其他名称：
|
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有源比较器：IV PCA
Intravenous fentanyl patient controlled analgesia
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fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Recovery - 40 score on discharge
大体时间：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.
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up to 5 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Duration of procedure
大体时间：24 hours
|
Duration of procedure from induction to abortion in hours
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24 hours
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Pain score
大体时间：24 hours
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Visual analog pain score every 30 minutes during procedure
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24 hours
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Narcotic-related complications
大体时间：24 hours
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Incidence of: nausea/vomiting, pruritis, sedation, respiratory depression.
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24 hours
|
|
Epidural-related complications
大体时间：24 hours
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Incidence of: hypotension, dural puncture, local anesthetic toxicity, neurological complications.
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24 hours
|
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Surgical intervention
大体时间：24 hours
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Incidence of surgical intervention and any anesthetic required for intervention.
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24 hours
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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