Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.
研究概览
详细说明
This randomised controlled study will include pre-operative screening with a 2 simple questionnaires and the patient will be randomised into a "choice" and "no choice" groups.
The group with the choice will be offered 2 different doses of intrathecal morphine (100, 200 mcg) which they can decide on after being given a standard script explaining advantages and disadvantages of each dose. Following cesarean section patients will be followed up at 3, 6, 12, 24, 36, 48 hours following spinal injection to assess severity of pain, time to first analgesia, total analgesia requirements, treatment of nausea, vomiting and pruritus.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Stanford、California、美国、94305
- Stanford University School of Medicine
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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:
- Women age 18-50 with singleton, term gestation fetuses and scheduled for their 1st, 2nd, or 3rd elective CS (not in labor) will be included.
Exclusion Criteria:
- 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:单组作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Choice Group
|
100 versus 200 mcg IT morphine
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有源比较器:No Choice Group
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100 versus 200 mcg IT morphine
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
pain scores (0-10) and analgesic use (morphine mg-equivalents) between the groups that have analgesic choice vs. no choice and among the actual doses received.
大体时间:up to 6 months
|
up to 6 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
preoperative questionnaire predictor scores versus postoperative pain and analgesic consumption post cesarean delivery.
大体时间:Baseline and day 1
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Baseline and day 1
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合作者和调查者
调查人员
- 首席研究员:Brendan Carvalho、Stanford University
出版物和有用的链接
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
与本研究相关的术语
其他研究编号
- SU-08172011-8271
- IRB 21802 (其他标识符:Stanford University IRB)
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.
Drug Dose的临床试验
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University of South CarolinaMedical University of South Carolina; National Institute on Deafness and Other Communication...完全的
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Jiangsu Province Centers for Disease Control and...Academy of Military Medical Sciences,Academy of Military Sciences,PLA; ZHONGYIANKE Biotech Co... 和其他合作者招聘中
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Fondazione Evidence per Attività e Ricerche Cardiovascolari...未知