Preoperative Education for Less Outpatient Pain After Surgery (PELOPS)

NCT ID: NCT03754699

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 412 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2025-09-15

Brief Summary

In 2015, more than 50% of surgical procedures were performed in outpatient settings. Successful pain management after outpatient surgery is crucial, and requires a perfect cooperation between caregivers and patients, with clear information on the analgesics use at home. Different strategies to control postoperative pain were adopted by hospitals performing outpatient surgery. However, up to half of patients receive little or no information about the treatment of postoperative pain, and at least one third of them are not able to follow postoperative analgesia instructions. There is a clear unmet need in pain treatment during first 48-72 hours after discharge, with important number of emergency calls and readmissions. The most common causes of rescue calls after outpatient surgery are uncontrolled pain and questions about medications or post-operative care.

Structured education interventions using psychological techniques to enhance engagement and behavior were found to be beneficial for better acute pain management in outpatient settings after orthopedic surgery.

We hypothesize that an educational intervention based on the rational perception of postoperative pain and discomfort, and the proper use of analgesics would improve the quality of pain management at home and reduce analgesics-related side effects.

Principal objective of this study is to evaluate the impact of a preoperative educational intervention on effectiveness of postoperative pain self-management in outpatient settings compared to the current practice.

Secondary objectives are to evaluate the prevalence of analgesics use and the incidence of severe pain episodes, as well as side effects. The occurrence of neurological pain, quality of sleep, and patient's comfort will be evaluated at 30th day after surgery.

Conditions

Outpatient Orthopedic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patients with a therapeutic educational intervention

Arm 1 : Interventional group: A therapeutic educational intervention is performed following pre-anesthesia assessment

Group Type: EXPERIMENTAL

Educational intervention

Intervention Type: BEHAVIORAL

During the usual pre-anesthesia assessment (performed between D-30 and D0 of the intervention), the anesthesiologist will deliver to the intervention group patient oral and visual information on:

• the numerical scale of pain ranging from 0 to 10 with examples of perceptions corresponding to each level of the scale (calibration)
• nature of postoperative pain (inflammatory character, dynamic over time)
• average pain level incurred by the intervention
• the difference between anti-inflammatory and opioid analgesics
• principles of systematic treatment and pain anticipation
• principles of overdose and side effects prevention This information is standardized and delivered orally, accompanied by a visual support (patient diary), which will be given to the patient upon discharge from the hospital

Patients without therapeutic educational intervention

Arm 2 : Control group: standard information on pain is performed following pre anesthesia assessment

Group Type: ACTIVE_COMPARATOR

Standard information

Intervention Type: BEHAVIORAL

Standard information on pain For patients in the control group the standardized information is based on the SG/DGM/DSS 1/41-2010 scheme of the AFSSAPS-CFETD repository.

Interventions

Educational intervention

During the usual pre-anesthesia assessment (performed between D-30 and D0 of the intervention), the anesthesiologist will deliver to the intervention group patient oral and visual information on:

• the numerical scale of pain ranging from 0 to 10 with examples of perceptions corresponding to each level of the scale (calibration)
• nature of postoperative pain (inflammatory character, dynamic over time)
• average pain level incurred by the intervention
• the difference between anti-inflammatory and opioid analgesics
• principles of systematic treatment and pain anticipation
• principles of overdose and side effects prevention This information is standardized and delivered orally, accompanied by a visual support (patient diary), which will be given to the patient upon discharge from the hospital

Intervention Type: BEHAVIORAL

Standard information

Standard information on pain For patients in the control group the standardized information is based on the SG/DGM/DSS 1/41-2010 scheme of the AFSSAPS-CFETD repository.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adults (age ≥ 18 years);
• Patients scheduled for outpatient orthopedic surgery
• ASA (American Society of Anesthesiology) I to III;
• Patients admitted for an outpatient intervention resulting in moderate to severe pain: eg: arthroscopy of the knee or shoulder, cruciate ligaments, shoulder block, medial patellofemoral ligament plasty (not exhaustive)

Exclusion Criteria

• Pregnant or lactating women
• Patients with contraindications to paracetamol and/or second-level analgesic and/or NSAIDs (hepatocellular insufficiency, respiratory insufficiency, substituted or unsubstituted drug addicts, allergy to one of the drugs, history of bleeding or digestive perforation during previous NSAID treatment, history of gastroduodenal ulcer, renal failure with clearance <50mL / min, severe heart failure)
• Patients with preoperative chronic pain (outside operative site, known or detected by DN4)
• Patients admitted for an outpatient arthroplasty (excluded because they are subjected of a specific preoperative preparation)
• Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social establishment for other purposes than research
• Patient with a poor understanding of French
• Patient refusing to participate to the study
• Patient not affiliated to a social security regimen
• Patient participating in other interventional research except a routine care research (former regulation) and/or research with no interference with the primary endpoint analysis as determined by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit

Lyon, , France

Countries

France

References

Dziadzko M, Bouteleux A, Minjard R, Harich J, Joubert F, Pradat P, Pantel S, Aubrun F. Preoperative Education for Less Outpatient Pain after Surgery (PELOPS trial) in orthopedic patients-study protocol for a randomized controlled trial. Trials. 2022 May 21;23(1):422. doi: 10.1186/s13063-022-06387-6.

Reference Type: DERIVED

PMID: 35598000 (View on PubMed)

Other Identifiers

2018-A00010-55

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0860

Identifier Type: -

Identifier Source: org_study_id