Severity Postoperative Pain Prediction

Wake Forest University (WFU)

Status: Terminated

Conditions: Postoperative Pain; Anxiety; Pain

Study type: Observational

Funder types: Other

Identifiers

NCT00638404

Pain Prediction

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

1

Description:

Elective Cesarean Sections-this portion completed

3

Description:

Any in-patient gynecologic procedure- this portion completed