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Providing Patients Realistic Expectations of Postoperative Pain (PPREOPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434847
Recruitment Status : Terminated (CMS questions to assess patient satisfaction of pain control were removed from the HCAHPS survey, leaving the study without intervention assessment.)
First Posted : February 15, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Other: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, single-blind study
Masking: Single (Participant)
Masking Description:

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, we will be using deception, 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.

Primary Purpose: Supportive Care
Official Title: The PPREOPP Study: Providing Patients Realistic Expectations of Postoperative Pain
Actual Study Start Date : October 21, 2017
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : January 16, 2018

Arm Intervention/treatment
No Intervention: Control
Standard preoperative assessment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434847


Locations
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United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Michael Bottros, MD Washington University School of Medicine
Additional Information:
Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03434847    
Other Study ID Numbers: 201709172
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms