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NCT Number: NCT03754699

Preoperative Education for Less Outpatient Pain After Surgery (PELOPS)

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.

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Key information

Conditions

Outpatient Orthopedic Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational intervention

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

Standard information

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: PELOPS

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2018
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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