Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03754699
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Outpatient Orthopedic Surgery Behavioral: Educational intervention Behavioral: Standard information Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Impact of a Preoperative Education on the Quality of Postoperative Analgesia Management in Outpatient Surgery
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
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 D-2 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754699


Contacts
Layout table for location contacts
Contact: Mikhaïl DZIADZKO +33 4 26 10 93 25 mikhail.dziadzko@chu-lyon.fr
Contact: Axelle BOUTELEUX +33 4 72 11 90 51 axelle.bouteleux@chu-lyon.fr

Locations
Layout table for location information
France
Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit Recruiting
Lyon, France, 69004
Contact: Mikhaïl DZIADZKO    +33 42 10 93 25    mikhail.dziadzko@chu-lyon.fr   
Contact: Axelle BOUTELEUX    +33 4 72 11 90 51    axelle.bouteleux@chu-lyon.fr   
Principal Investigator: Mikhaïl DZIADZKO         
Sponsors and Collaborators
Hospices Civils de Lyon

Layout table for additonal information
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03754699     History of Changes
Other Study ID Numbers: 69HCL17_0860
2018-A00010-55 ( Other Identifier: ANSM )
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Pain
Surgery
Preoperative Education
Outpatient
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs