Programmed Intermittent Bolus Dosing Versus Continuous Epidural Infusion for Epidural Analgesia in Abdominal Surgery.
A Prospective, Randomized Analysis of Epidural Anesthesia Using Programmed Intermittent Epidural Boluses Versus Continuous Epidural Infusion in Patients Undergoing Abdominal Surgery.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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California
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San Francisco、California、美国、94158
- University of California San Francisco
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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:
- American Society of Anesthesia physical classification I - III, scheduled for surgery with anticipated an epidural anesthesia (including but not limited to colorectal, surgical oncology, urology, gynecology) as part of their perioperative treatment
Exclusion Criteria:
- Age younger than 18 years of age, non-English speaking, contraindication for neuraxial anesthesia (such as, but not limited to coagulopathy, infection at site, allergy to local anesthetic), preexisting neurologic deficits, inability to consent due to cognitive dysfunction, patients with pain numeric rating score > 5 each day for greater than 3 months, daily opioid consumption > 100 oral morphine equivalents for 14 consecutive days prior to surgery, patient refusal.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Continuous epidural infusion
At our institution, the most commonly utilized form of administration of medication through an epidural (our active comparator/control) is as follows: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl infused at a constant rate of 8ml/hr. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 15 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. |
其他名称：
其他名称：
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实验性的：Programmed intermittent epidural bolus
For the programmed intermittent epidural bolus group: Combination of 0.0625% bupivacaine with 2mcg/ml of fentanyl will be administered as a bolus of 4ml every 30 minutes. The patient has the ability to self administer patient controlled epidural analgesia of 2ml of the epidural medication with a lock out period of 10 min. The total maximum volume of epidural medication each hour is 16ml. These settings are managed and controlled by a epidural medication pump. Additional oral and intravenous analgesia medications are available as scheduled and pro re nata. |
其他名称：
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 |
|---|---|---|
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Total Local Anesthetic Utilized in First 24 Hours
大体时间：In first 24 hours
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Total local anesthetic consumed while epidural in place, recorded on infusion pump
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In first 24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total Opioid Consumed
大体时间：While epidural in place (up to 72 hours post operatively)
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Total opioid consumed (intravenous or po) while epidural in place
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While epidural in place (up to 72 hours post operatively)
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Patient Satisfaction Score
大体时间：While epidural in place (up to 72 hours postoperatively)
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Ranked patient satisfaction scores while epidural in place. Measured by modified pain inventory. Minimum is 0, maximum of 10. 10 indicates highest patient satisfaction. |
While epidural in place (up to 72 hours postoperatively)
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Average Pain Severity
大体时间：While epidural in place (up to 72 hours postoperatively)
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Measured by modified pain inventory on a daily basis while epidural in place.
Minimum is 0, maximum is 10. 10 indicates highest pain severity.
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While epidural in place (up to 72 hours postoperatively)
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Incidence of Hypotension
大体时间：While epidural in place (24 hours postoperatively)
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Most common side effect post-operatively with epidural anesthesia.
Documented by recorded vitals signs, fluid resuscitation, and temporary cessation of epidural medication.
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While epidural in place (24 hours postoperatively)
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Worst Reported 24 Hour Pain
大体时间：While epidural in place (up to 72 hours postoperatively)
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Minimum is 0, maximum is 10. 10 indicates highest pain severity.
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While epidural in place (up to 72 hours postoperatively)
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Average Pain Interference
大体时间：While epidural in place (up to 72 hours postoperatively)
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Minimum is 0, maximum is 10. 10 indicates highest pain interference.
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While epidural in place (up to 72 hours postoperatively)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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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