Preoperative Education for Less Outpatient Pain After Surgery (PELOPS) (PELOPS)

January 27, 2026 updated by: Hospices Civils de Lyon

Impact of a Preoperative Education on the Quality of Postoperative Analgesia Management in Outpatient Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69004
        • Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with a therapeutic educational intervention
Arm 1 : Interventional group: A therapeutic educational intervention is performed following pre-anesthesia assessment
Behavioral: 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
Active Comparator: Patients without therapeutic educational intervention
Arm 2 : Control group: standard information on pain is performed following pre anesthesia assessment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR) during 5 postoperative days
Time Frame: Day 5
TOTPAR is a global score based on relief of pain. A numerical scale has at its left end the words "no relief = 0" and at its right end "complete relief = 100%". The pain relief score is calculated using the area under the curve for a defined period of time. TOTPAR is also expressed as a percentage of the maximum TOTPAR that would be achieved by treatment that would provide complete relief during the observation period. In order to measure this area under the curve, at least 3 measurements per day will have to be reported in the patient diary.
Day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR)
Time Frame: At Day 10, Day 20 and Day 30 with the initial point at Day 5
TOTPAR is a global score based on relief of pain. A numerical scale has at its left end the words "no relief = 0" and at its right end "complete relief = 100%". The pain relief score is calculated using the area under the curve for a defined period of time. TOTPAR is also expressed as a percentage of the maximum TOTPAR that would be achieved by treatment that would provide complete relief during the observation period. In order to measure this area under the curve, at least 3 measurements per day will have to be reported in the patient diary.
At Day 10, Day 20 and Day 30 with the initial point at Day 5
Type, number and doses of prescribed analgesics
Time Frame: At Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 10, Day 20 and Day 30.
Patient will report drug intake on a patient diary
At Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 10, Day 20 and Day 30.
Incidence of severe pain (≥ 7 out of 10).
Time Frame: From day 0 to the end of stidy (Day 30)
The patient diary will provide a continuous assessment at home of the pain intensity
From day 0 to the end of stidy (Day 30)
Incidence of side effects (nausea / vomiting / gastralgia / dizziness / concentration disorder / somnolence / constipation, other).
Time Frame: From day 0 to the end of stidy (Day 30)
Side effects will be collected on the patient diary
From day 0 to the end of stidy (Day 30)
Prevalence of neuropathic pain assessed by using the DN4 scale.
Time Frame: At Day 30
Patient will complete the DN4 questionnaires the day of the pre-anesthetic consultation and at Day 30 on the patient diary.
At Day 30
Sleep quality at day 0 and day 30 by the Pittsburgh Sleep Quality Index
Time Frame: At Day 0 and Day 30
Patient will complete the PSQI questionnaires the day of the pre-anesthetic consultation and at Day 30 on the patient diary.
At Day 0 and Day 30
Comfort and experience of the patient evaluated by the International Pain Outcome questionnaire.
Time Frame: At Day 30
Patient will complete the International Pain Outcome questionnaire at day 30, on the patient diary
At Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL17_0860
  • 2018-A00010-55 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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