Predicting Severity of Postoperative Pain After Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evoked Pain at 24 Hours VAS
研究概览
简要总结
A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •< 36 weeks for Cesarean Section
- •< 18 years of age
结局指标
主要结局
Evoked Pain at 24 Hours VAS
时间窗: 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
次要结局
- Anticipated Pain Medication Requirement(24 hours)
- Anticipated Postoperative Pain at Preoperative Evaluation(anticipated postoperative pain)
- Anxiety(anticipated anxiety prior to surgery)
