The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population
2014年8月31日 更新者：Xianwei Zhang
This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery.
Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study.
Genotyping of SCN9A was carried out by direct sequencing.
The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO).
The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation.
And the PCA press frequency and drug consumption were recorded.
研究概览
详细说明
Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.
研究类型
观察性的
注册 (实际的)
200
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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Hubei
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Wuhan、Hubei、中国、430030
- Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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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
20年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
800 Chinese patients receiving elective upper abdominal surgery under general anesthesia
描述
Inclusion Criteria:
- Aged 20-70 years
- Receiving elective upper abdominal surgery
- Anesthesiologists (ASA) physical status I or II
- Received PCA administration
- Agreed to participate the research
Exclusion Criteria:
- History of chronic pain
- Psychiatric diseases
- Diabetes mellitus
- Severe cardiovascular diseases
- Kidney or liver diseases
- Alcohol or drug abuse
- Heavy smoker
- Pregnancy or at lactation period
- Refused PCA administration
- Disagree to participate to the research
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？
队列和干预
团体/队列 |
|---|
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mutant alleles
grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
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wild-type alleles
grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Opioid Consumption Dose 48h After Operation.
大体时间：48 hours after the operation
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48 hours after the operation
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PCA Press Frequency 48h After Operation.
大体时间：48 hours after the operation
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48 hours after the operation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Visual Analog Scale 48h After Operation.
大体时间：48 hours after the operation
|
The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation.
And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain
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48 hours after the operation
|
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Preoperative Pressure Pain Threshold (PPT)
大体时间：12 hours before the operation
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The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer.
subjects were asked to say "pain" when they started to feel pain during the stimulation.
The value from the LCD was recorded as the pressure pain threshold.
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12 hours before the operation
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Preoperative Pressure Pain Tolerance (PTO)
大体时间：12 hours before the operation
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The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer.
subjects were asked to say "ok" when they started to feel the pain became intolerable during the stimulation.
The value from the LCD was recorded as the pressure pain tolerance.
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12 hours before the operation
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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。
调查人员
- 研究主任：Zhang Xianwei, Doctor、Huazhong University of Science and Technology
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
2011年1月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2012年1月2日
首先提交符合 QC 标准的
2012年1月6日
首次发布 (估计)
2012年1月11日
研究记录更新
最后更新发布 (估计)
2014年9月3日
上次提交的符合 QC 标准的更新
2014年8月31日
最后验证
2014年8月1日
更多信息
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.