Providing Patients Realistic Expectations of Postoperative Pain

Not Applicable

Terminated

• Conditions: Pain, Postoperative
• Interventions: Other: Education

• Registration Number: NCT03434847
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Prospective, randomized, single-blind study, whether perioperative educational improves pain-related postoperative outcomes,

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-21
• Study First Submitted: 2017-12-14
• Primary Completion: 2018-01-16
• Study Completion: 2018-01-16
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Age > 18 years
• Undergoing open colorectal surgery Able to understand and sign and informed consent form

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Education	Pre-operative education regarding post-operative pain expectations

Primary Outcome Measures

Name	Time	Method
Does perioperative education improve satisfaction with postoperative pain control at discharge?	Upon discharge, Day 1 - Day 7	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.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States