Pain, Postoperative
Conditions
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.
Interventions
OTHEREducation
Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Intervention model description
Prospective, randomized, single-blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed