Preoperative Education for Less Outpatient Pain After Surgery (PELOPS)

Not Applicable

Recruiting

• Conditions: Outpatient Orthopedic Surgery
• Interventions: Behavioral: Standard information; Behavioral: Educational intervention

• Registration Number: NCT03754699
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-23
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Start: 2019-01-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-03-31
• Primary Completion: 2025-01-27
• Study Completion: 2025-04-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 414

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without therapeutic educational intervention	Standard information	Arm 2 : Control group: standard information on pain is performed following pre anesthesia assessment
Patients with a therapeutic educational intervention	Educational intervention	Arm 1 : Interventional group: A therapeutic educational intervention is performed following pre-anesthesia assessment

Primary Outcome Measures

Name	Time	Method
Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR) during 5 postoperative days	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 Outcome Measures

Name	Time	Method
Type, number and doses of prescribed analgesics	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
Incidence of severe pain (≥ 7 out of 10).	From day 0 to the end of stidy (Day 30)	The patient diary will provide a continuous assessment at home of the pain intensity
Comfort and experience of the patient evaluated by the International Pain Outcome questionnaire.	At Day 30	Patient will complete the International Pain Outcome questionnaire at day 30, on the patient diary
Incidence of side effects (nausea / vomiting / gastralgia / dizziness / concentration disorder / somnolence / constipation, other).	From day 0 to the end of stidy (Day 30)	Side effects will be collected on the patient diary
Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR)	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.
Prevalence of neuropathic pain assessed by using the DN4 scale.	At Day 30	Patient will complete the DN4 questionnaires the day of the pre-anesthetic consultation and at Day 30 on the patient diary.
Sleep quality at day 0 and day 30 by the Pittsburgh Sleep Quality Index	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.

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit; 🇫🇷 Lyon, France