Providing Patients Realistic Expectations of Postoperative Pain

ID: NCT03434847
Status: Recruiting
Phase: N/A
Start Date: October 21, 2017
First Submitted: December 14, 2017
Last Updated: February 13, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Pain, Postoperative
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Study Description

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.
Condition or disease Intervention/treatment Phase

Pain, Postoperative

Other: Education
Other Names
N/A

Tracking Information

First Submitted DateDecember 14, 2017
Last Update Posted DateFebruary 13, 2018
Actual Start DateOctober 21, 2017
Anticipated Completion DateSeptember 20, 2018
Actual Primary Completion DateSeptember 20, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Does perioperative education improve satisfaction with postoperative pain control at discharge? [Time Frame: 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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleProviding Patients Realistic Expectations of Postoperative Pain
Official TitleThe PPREOPP Study: Providing Patients Realistic Expectations of Postoperative Pain
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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
100
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Supportive Care
Conditions
Pain, Postoperative
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Other: Education

Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.

Other Names
Study Groups/Cohorts
Control
Standard preoperative assessment

Education
Pre-operative education regarding post-operative pain expectations

Study Arms
Active Comparator Education
Pre-operative education regarding post-operative pain expectations
Other : Education
Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.

Arm Intervention/Treatment
Active Comparator Education
Pre-operative education regarding post-operative pain expectations
Other : Education

Recruitment Information

Recruitment Status:Recruiting
Enrollment100
Completion DateSeptember 20, 2018
Eligibility Criteria: 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)
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03434847
Other Study ID Numbers
201709172
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Michael Bottros, MD
Washington University School of Medicine

Publications