Providing Patients Realistic Expectations of Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-21

Study Completion Date

2018-01-16

Brief Summary

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

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, single-blind study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Control

Standard preoperative assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Education

Pre-operative education regarding post-operative pain expectations

Group Type ACTIVE_COMPARATOR

Education

Intervention Type OTHER

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

Interventions

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Education

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

Intervention Type OTHER

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No