Severity Postoperative Pain Prediction
|Study Design:||Time Perspective: Prospective|
|Official Title:||Predicting Severity of Postoperative Pain After Surgery|
- 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. [ Time Frame: Preoperative testing with postoperative followup up to 48 hours postop ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Elective Cesarean Sections-this portion completed
Any in-patient gynecologic procedure- this portion completed
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638404
|United States, North Carolina|
|Forsyth Medical Center|
|Winston-Salem, North Carolina, United States, 27103|
|Principal Investigator:||Peter H. Pan, MSEE, MD||Wake Forest School of Medicine|