Opioid Prescribing After Cesarean Delivery
2019年2月22日 更新者：Sarah Osmundson、Vanderbilt University Medical Center
A Randomized Controlled Trial to Improve Discharge Opioid Prescribing After Cesarean Delivery
The number of opioid overdose deaths in the United States has quadrupled in 15 years, a dramatic manifestation of the current opioid abuse epidemic.
This rise parallels a sharp increase in the amount of legal prescription opioids dispensed.
The abundance of prescription opioids available is a primary pathway for opioid abuse and diversion.
Adjusting post- cesarean delivery opioid prescribing practices to better match actual patient need has the potential to reduce unused opioids available for diversion, nonmedical use, and development of chronic dependence, as well as reduce wasted resources.
研究概览
详细说明
Preliminary data from a quality improvement project performed in our department found that most women are prescribed opioids after discharge that were significantly in excess of the actual opioids used.
However there is a subset of women (~25%) who use all opioids and complain that they were not prescribed enough.
The only variable predictive of post- discharge opioid use was Inpatient opioid use.
These data were used to develop a formula for estimating outpatient use based on inpatient use.
Currently there are no guidelines for outpatient prescribing either at our institution or on a national level.
On average, most patients at our institution received 30 tablets of 5mg oxycodone at discharge.
In surveying providers, very few looked at inpatient use and most had a standard prescription that they gave everyone.
研究类型
介入性
注册 (实际的)
190
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Tennessee
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Nashville、Tennessee、美国、37215
- Sarah Osmundson
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women 18-50 years old
- Women undergoing cesarean delivery at a single institution
Exclusion Criteria:
- Major post-surgical complications: cesarean hysterectomy, bowl or bladder injury, reoperation, ICU admission, wound infection or separation
- Chronic opioid use: Taking buprenorphine during pregnancy, taking an opioid for > 7 days during pregnancy.
- Non English or Spanish speaking
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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 |
|---|---|
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实验性的：Tailored
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
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Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
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其他：Control
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
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Participants will be prescribed 30 tablets of oxycodone 5mg
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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 |
|---|---|---|
|
Unused Opioids
大体时间：4 weeks postpartum
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oxycodone 5mg tablet leftover from prescription at discharge
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4 weeks postpartum
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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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Pain: Frequency That Participants Reported Uncontrolled Pain
大体时间：4 weeks postpartum
|
Frequency that participants reported uncontrolled pain Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5. Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0) |
4 weeks postpartum
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年6月14日
初级完成 (实际的)
2017年9月21日
研究完成 (实际的)
2017年9月21日
研究注册日期
首次提交
2017年5月22日
首先提交符合 QC 标准的
2017年5月25日
首次发布 (实际的)
2017年5月30日
研究记录更新
最后更新发布 (实际的)
2019年6月3日
上次提交的符合 QC 标准的更新
2019年2月22日
最后验证
2019年2月1日
更多信息
与本研究相关的术语
其他研究编号
- OSMUNDSS04192017181235
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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