Clinical trial NCT03808220: Prospective Observational Study on Postoperative Pain and Side Effect
Official title: Improvement in Postoperative Pain Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 2197
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult post-surgical patients in hospitals on post-op day 1

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Questionnaire on postoperative pain treatment
timeFrame: first postoperative day
Secondary outcomes:
measure: Questionnaire on patients' perception of pain treatment outcome
timeFrame: first postoperative day
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: Jena University Hospital
name: Winfried Meissner
role: STUDY_DIRECTOR
affiliation: The University of Hong Kong
name: Chi Wai Cheung, MD
role: PRINCIPAL_INVESTIGATOR
References: