Providing Patients Realistic Expectations of Postoperative Pain (PPREOPP)

The Washington University

Status

Terminated

Conditions

Pain, Postoperative

Treatments

Other: Education

Study type

Interventional

Funder types

Other

Identifiers

NCT03434847

201709172

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)