Preoperative Education for Less Outpatient Pain After Surgery (PELOPS) (PELOPS)
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|ClinicalTrials.gov Identifier: NCT03754699|
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : January 25, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||414 participants|
|Intervention Model:||Parallel Assignment|
|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|
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:
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.
- 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.
- 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.
- 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
- 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
- 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
- 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.
- 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.
- 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
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
|Contact: Mikhaïl DZIADZKO||+33 4 26 10 93 email@example.com|
|Contact: Axelle BOUTELEUX||+33 4 72 11 90 firstname.lastname@example.org|
|Hospices Civils de Lyon - Hopital de la Croix Rousse - Anaesthesia Reanimation unit||Recruiting|
|Lyon, France, 69004|
|Contact: Mikhaïl DZIADZKO +33 42 10 93 25 email@example.com|
|Contact: Axelle BOUTELEUX +33 4 72 11 90 51 firstname.lastname@example.org|
|Principal Investigator: Mikhaïl DZIADZKO|