Clinical trial NCT03754699: Preoperative Education for Less Outpatient Pain After Surgery (PELOPS)
Official title: Impact of a Preoperative Education on the Quality of Postoperative Analgesia Management in Outpatient Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Outpatient Orthopedic Surgery
Keywords: Pain
Surgery
Preoperative Education
Outpatient
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR) during 5 postoperative days
timeFrame: Day 5
Secondary outcomes:
measure: Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR)
timeFrame: At Day 10, Day 20 and Day 30 with the initial point at Day 5
measure: Type, number and doses of prescribed analgesics
timeFrame: At Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 10, Day 20 and Day 30.
measure: Incidence of severe pain (≥ 7 out of 10).
timeFrame: From day 0 to the end of stidy (Day 30)
measure: Incidence of side effects (nausea / vomiting / gastralgia / dizziness / concentration disorder / somnolence / constipation, other).
timeFrame: From day 0 to the end of stidy (Day 30)
measure: Prevalence of neuropathic pain assessed by using the DN4 scale.
timeFrame: At Day 30
measure: Sleep quality at day 0 and day 30 by the Pittsburgh Sleep Quality Index
timeFrame: At Day 0 and Day 30
measure: Comfort and experience of the patient evaluated by the International Pain Outcome questionnaire.
timeFrame: At Day 30
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit
Study officials:
References:
citation: 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.