PAIN OUT: Improvement in Postoperative PAIN OUTcome

Recruiting

• Conditions: Post-operative Pain

• Registration Number: NCT02083835
• Lead Sponsor: University of Jena

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:

1. 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.

2. a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations.

PAIN OUT is leading and overseeing sub-projects in Mexico, China, a number of European countries. Additional countries will join over time. The sub-projects are scheduled to take place over a period of two years. The design is an uncontrolled pre- post-study, in which approximately 10 hospitals from each country participate. The project consists of collecting data (processes and patient reported outcomes) at baseline from 1-3 wards in participating hospitals; analyzing of the findings, selecting and implementing measures for change in practice; carrying out another round of data collection; summerizing the findings and discussing options for further work.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of postoperative pain treatment	first postoperative day

Secondary Outcome Measures

Name	Time	Method
patients' perception of pain treatment outcome	first postoperative day	* 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; * pre-hospital existence of pain

Trial Locations

Locations (1)

Jena University Hospital; 🇩🇪 Jena, Germany