跳至主要内容
临床试验/NCT00638404
NCT00638404终止不适用

Predicting Severity of Postoperative Pain After Surgery

Wake Forest University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年8月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验