Outpatient Orthopedic SurgeryPELOPSNCT03754699
Preoperative Education for Less Outpatient Pain After Surgery (PELOPS)
A study testing Educational intervention and Standard information in people with Outpatient Orthopedic Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Outpatient Orthopedic Surgery
- What is being tested?
- Educational intervention and Standard information
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2019to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit
Lyon, 69004
About this study
Official title: 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.
Read more
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
- Being tested
- Educational intervention, Standard information
- Keywords
- Pain, Surgery, Preoperative Education, Outpatient
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
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 informationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a therapeutic educational intervention | Experimental | Arm 1 : Interventional group: A therapeutic educational intervention is performed following pre-anesthesia assessment Receives: Behavioral: Educational intervention |
| Patients without therapeutic educational intervention | Active comparator | Arm 2 : Control group: standard information on pain is performed following pre anesthesia assessment Receives: Behavioral: Standard information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR) during 5 postoperative days
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.
Measured: Day 5
Secondary outcomes (7)
Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR)
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.
Measured: At Day 10, Day 20 and Day 30 with the initial point at Day 5
Type, number and doses of prescribed analgesics
Patient will report drug intake on a patient diary
Measured: 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).
The patient diary will provide a continuous assessment at home of the pain intensity
Measured: From day 0 to the end of stidy (Day 30)
Incidence of side effects (nausea / vomiting / gastralgia / dizziness / concentration disorder / somnolence / constipation, other).
Side effects will be collected on the patient diary
Measured: From day 0 to the end of stidy (Day 30)
Prevalence of neuropathic pain assessed by using the DN4 scale.
Patient will complete the DN4 questionnaires the day of the pre-anesthetic consultation and at Day 30 on the patient diary.
Measured: At Day 30
Sleep quality at day 0 and day 30 by the Pittsburgh Sleep Quality Index
Patient will complete the PSQI questionnaires the day of the pre-anesthetic consultation and at Day 30 on the patient diary.
Measured: At Day 0 and Day 30
Comfort and experience of the patient evaluated by the International Pain Outcome questionnaire.
Patient will complete the International Pain Outcome questionnaire at day 30, on the patient diary
Measured: At Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start22 Jan 2019
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Outpatient Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754699
- Sponsor's protocol ID
- 69HCL17_0860
- Other IDs
- 2018-A00010-55
- Acronym
- PELOPS
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2018
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35598000
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Preoperative Education on the Quality of Postoperative Analgesia Management in Outpatient Surgery
- ClinicalTrials.gov ID
- NCT03754699
- Acronym / sponsor ID
- PELOPS / 69HCL17_0860
- Conditions
- Outpatient Orthopedic Surgery
- Keywords
- Pain, Surgery, Preoperative Education, Outpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 412 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a therapeutic educational intervention | Experimental | Behavioral: Educational interventionArm 1 : Interventional group: A therapeutic educational intervention is performed following pre-anesthesia assessment |
| Patients without therapeutic educational intervention | Active comparator | Behavioral: Standard informationArm 2 : Control group: standard information on pain is performed following pre anesthesia assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionDuring 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 | Behavioural | Patients with a therapeutic educational intervention |
| Standard informationStandard 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. | Behavioural | Patients without therapeutic educational intervention |
Primary outcome
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.
7 secondary outcomes
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
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.
Incidence of severe pain (≥ 7 out of 10).
Time frame: 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)
Prevalence of neuropathic pain assessed by using the DN4 scale.
Time frame: 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
Comfort and experience of the patient evaluated by the International Pain Outcome questionnaire.
Time frame: At Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 35598000Dziadzko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention and Standard information in people with Outpatient Orthopedic Surgery, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted sum of Pain Relief - Total Pain Relief (TOTPAR) during 5 postoperative days (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03754699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.