Severity Postoperative Pain Prediction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Predicting Severity of Postoperative Pain After Surgery

Conditions
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Anxiety, Pain, Postoperative Pain

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Elective Cesarean Sections-this portion completed | |
| 3<br>Any in-patient gynecologic procedure- this portion completed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evoked Pain at 24 Hours VAS | Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain | evoked pain at 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated Pain Medication Requirement | measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required | 24 hours | 
| Anticipated Postoperative Pain at Preoperative Evaluation | anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable | anticipated postoperative pain | 
| Anxiety | measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious | anticipated anxiety prior to surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative somatic questions, Preoperative audio tone evaluations, Preoperative anxiety and previous experience with postop pain