Providing Patients Realistic Expectations of Postoperative Pain

Study Overview
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Brief Summary
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Prospective, randomized, single-blind study, whether perioperative educational improves pain-related postoperative outcomes,

Detailed Description
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This is a prospective, randomized, single-blind study in 100 patients undergoing open colorectal surgery. If the hypothesis is confirmed, then patients who receive perioperative educational interventions to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes. Randomization and Blinding 100 eligible patients scheduled to undergo open colorectal surgery will be approached in the Center for Preoperative Assessment and Planning Clinic. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine whether they will be in the intervention or control arm. Pre-operatively, all patients will complete an initial questionnaire. The patients in the intervention group (n=50) will, in addition to the standard pre-operative assessment, also receive pre-operative educational instruction of what to expect from a post-operative pain perspective including education material to take home. For this study, deception will be used, with the reasoning that the patients' knowledge of the different education materials will affect their rating of the impact of the intervention on satisfaction scores.

Official Title
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The PPREOPP Study: Providing Patients Realistic Expectations of Postoperative Pain

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Undergoing open colorectal surgery Able to understand and sign and informed consent form Exclusion Criteria: Age < 18 years Unable to complete post-operative CMS questionnaire Inability to understand the English language Absolute contraindication to epidural placement (patient refusal, requiring resumption of therapeutic anticoagulation after surgery, anaphylaxis to local anesthetics, local or systemic infections, bleeding diathesis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, single-blind study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard preoperative assessment | |
| Active Comparator: Education<br>Pre-operative education regarding post-operative pain expectations | Other: Education<br>* Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does perioperative education improve satisfaction with postoperative pain control at discharge? | The satisfaction with postoperative pain control will be assessed using an initial, post-operative and discharge questionnaire of participant's pain level, medications (if any) to manage pain, the affects of that pain management, and participant satisfaction of that pain control. | Upon discharge, Day 1 - Day 7 |