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Prospective Observational Study on Postoperative Pain and Side Effect

Improvement in Postoperative Pain Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03808220
Acronym
Pain Out
Enrollment
2197
Registered
2019-01-17
Start date
2019-01-20
Completion date
2021-07-26
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

BEHAVIORALpostoperative pain intensity

estimate the postoperative pain intensity by using a scaling system via questionnaire

BEHAVIORALpreoperative pain frequency

estimate the preoperative pain intensity by using a scaling system via questionnaire

BEHAVIORALSide effect

investigate the presence of any side effect

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Questionnaire on postoperative pain treatmentfirst postoperative day

Secondary

MeasureTime frameDescription
Questionnaire on patients' perception of pain treatment outcomefirst postoperative dayquestions 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026