Severity Postoperative Pain Prediction
Predicting Severity of Postoperative Pain After Surgery
研究概览
详细说明
The purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery.
Study Design: A total of 400 evaluable patients will be studied using the various surgical populations listed. For statistical purposes, the following will be the surgical population by procedure. Two hundred healthy ASA I-II women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. Normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. The patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. At 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. Information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. The subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.
研究类型
注册 (实际的)
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27103
- Forsyth Medical Center
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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
取样方法
研究人群
描述
Inclusion Criteria:
- Healthy ASA physical status class 1 or 2
- Aged 18 years or above
- Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections
Exclusion Criteria:
- ASA >3
- < 36 weeks for Cesarean Section
- < 18 years of age
学习计划
研究是如何设计的?
设计细节
- 观测模型:其他
- 时间观点:预期
队列和干预
团体/队列 |
|---|
|
1
Elective Cesarean Sections-this portion completed
|
|
3
Any in-patient gynecologic procedure- this portion completed
|
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 |
|---|---|---|
|
Evoked Pain at 24 Hours VAS
大体时间:evoked pain at 24 hours
|
Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain
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evoked pain at 24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anticipated Pain Medication Requirement
大体时间:24 hours
|
measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required
|
24 hours
|
|
Anticipated Postoperative Pain at Preoperative Evaluation
大体时间:anticipated postoperative pain
|
anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable
|
anticipated postoperative pain
|
|
Anxiety
大体时间:anticipated anxiety prior to surgery
|
measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious
|
anticipated anxiety prior to surgery
|
合作者和调查者
调查人员
- 首席研究员:Peter H. Pan, MSEE, MD、Wake Forest University Health Sciences
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 (实际的)
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
关键字
其他研究编号
- Pain Prediction
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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