Prospective Observational Study on Postoperative Pain and Side Effect

Study Overview
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Brief Summary
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PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

Detailed Description
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PAIN OUT offers a large registry as well as a system for benchmarking and feedback of outcome quality and decision support in acute pain conditions. It collects demographic, clinical and outcome data, using a validated assessment tool available in multiple languages. The registry part of the project aims at performing population-based research. Furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care. The benchmark part of the project provides the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. A web-based information system, featuring two main functions, was developed: a feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice. a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations. From 2016 on, sub-projects in Mexico, China and several European countries have started. This programs take place over a period of two years during which collaborators carry out a Quality Improvement project in their hospital using methodology provided by PAIN OUT. This includes collection of baseline data in a first phase, analysis of findings according to a protocol provided by PAIN OUT, review of findings and developement of improvement measures, implementation of the improvements and assessment of outcomes after a second phase of data collection.

Official Title
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Improvement in Postoperative Pain Outcome

Conditions
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Postoperative Pain

Intervention / Treatment
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* Behavioral: postoperative pain intensity
* Behavioral: preoperative pain frequency
* Behavioral: Side effect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 years or >= 4 years for sub-project QUIPSI/PAIN OUTinfant patient is post-op day 1 patient is at least 6 hours on the ward patient has given consent Exclusion Criteria: patient cannot communicate patient is cognitively impaired patient is asleep patient is too ill patient does not want to fill in the questionnaire

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| post-surgical patients<br>post-surgical patients > 18 years | Behavioral: postoperative pain intensity<br>* estimate the postoperative pain intensity by using a scaling system via questionnaire<br>Behavioral: preoperative pain frequency<br>* estimate the preoperative pain intensity by using a scaling system via questionnaire<br>Behavioral: Side effect<br>* investigate the presence of any side effect<br>|
| pediatric patients post-op day 1<br>pediatric patients > 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant) | Behavioral: postoperative pain intensity<br>* estimate the postoperative pain intensity by using a scaling system via questionnaire<br>Behavioral: preoperative pain frequency<br>* estimate the preoperative pain intensity by using a scaling system via questionnaire<br>Behavioral: Side effect<br>* investigate the presence of any side effect<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on postoperative pain treatment |  | first postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on patients' perception of pain treatment outcome | questions related to worst pain since surgery, least pain since surgery, time in pain, interference of pain with activities, affect of pain on mood and emotions, pain therapy side effects, pain relief, wish for more treatment, information on treatment, participation in decisions, satisfaction, non-medical treatment methods and pre-hospital existence of pain. | first postoperative day |