Preoperative Education for Less Outpatient Pain after Surgery (PELOPS trial) in orthopedic patients-study protocol for a randomized controlled trial.

Background: Successful pain management after outpatient surgery requires proper education leading to correct decisions on the analgesics use at home. Despite different strategies adopted, up to ½ of patients receive little or no information about the treatment of postoperative pain, 1/3 of them are not able to follow postoperative analgesia instructions. This leads to higher rates of unmet needs in pain treatment, post-discharge emergency calls, and readmissions. Structured educational interventions using psychological empowering techniques may improve postoperative pain management. We hypothesize that preoperative education on use of an improved pain scale to make correct pain management decisions will improve the quality of post-operative pain management at home and reduce analgesics-related side effects.

Methods: A total of 414 patients scheduled for an outpatient orthopedic surgery (knee/shoulder arthroscopic interventions) are included in this randomized (1:1) controlled trial. Patients in the control arm receive standard information on post-discharge pain management. Patients in the experimental arm receive structured educational intervention based on the rational perception of postoperative pain and discomfort (anchoring and improved pain scale), and the proper use of analgesics. There is no difference in post-discharge analgesics regimen in both arms. Patients are followed for 30 days post-discharge, with the primary outcome expressed as total pain relief score at 5 days. Secondary outcomes include the incidence of severe pain during 30 days, changes in sleep quality (Pittsburg Sleep Quality Assessment), and patients' perception of postoperative pain management assessed with the International Pain Outcomes questionnaire at day 30 post-discharge.

Discussion: The developed intervention, based on an improved pain scale, offers the advantages of being non-surgery-specific, is easily administered in a short amount of time, and can be delivered individually or in-group, by physicians or nurses.

Trial Registration: ClinicalTrials.gov NCT03754699 . Registered on November 27, 2018.