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Clinical Trials/NCT00638404
NCT00638404
Terminated
Not Applicable

Predicting Severity of Postoperative Pain After Surgery

Wake Forest University1 site in 1 country300 target enrollmentAugust 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Wake Forest University
Enrollment
300
Locations
1
Primary Endpoint
Evoked Pain at 24 Hours VAS
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
September 2009
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • \< 36 weeks for Cesarean Section
  • \< 18 years of age

Outcomes

Primary Outcomes

Evoked Pain at 24 Hours VAS

Time Frame: 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

Secondary Outcomes

  • Anticipated Pain Medication Requirement(24 hours)
  • Anticipated Postoperative Pain at Preoperative Evaluation(anticipated postoperative pain)
  • Anxiety(anticipated anxiety prior to surgery)

Study Sites (1)

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