Hydromorphone and C-section
Determination of the ED50 of Intrathecal Hydromorphone for Post-cesarean Section Pain Relief
This study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. Secondary objectives include determining the average amount of time patients obtain pain relief after injection. Other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. The starting dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.
After the intrathecal injection is given, patients will undergo their cesarean section. The patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. The patient's medical record will be reviewed to determine when she first requested supplemental pain medication. A pain score of less than three will be a positive result. A pain score of three or greater will be a negative result. Blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be assessed.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30303
- Grady Memorial 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:
- Healthy women undergoing cesarean section
Exclusion Criteria:
- Any comorbidities other than obesity, hypertension, fetal anomalies
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Hydromorphone
Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally
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Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
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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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Pain Scores, Visual Analogue Pain Scale
大体时间:12 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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12 hours after intrathecal injection
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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 Scores, Visual Analogue Pain Scale
大体时间:Baseline
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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Baseline
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Pain Scores, Visual Analogue Pain Scale
大体时间:6 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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6 hours after intrathecal injection
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Pain Scores, Visual Analogue Pain Scale
大体时间:18 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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18 hours after intrathecal injection
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Pain Scores, Visual Analogue Pain Scale
大体时间:24 hours after intrathecal injection
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Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).
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24 hours after intrathecal injection
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合作者和调查者
调查人员
- 首席研究员:Grant C Lynde, MD、Emory University
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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