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NCT Number: NCT02083835

PAIN OUT: Improvement in Postoperative PAIN OUTcome

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

Recruiting

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Key information

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jena University Hospital

Jena, 07747, Germany

Location status: Recruiting

Location contact

Winfried Meissner, Prof.

CONTACT

+49 3641 9323353

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assessment of postoperative pain treatment

    Time frame: first postoperative day

Secondary outcomes

  1. patients' perception of pain treatment outcome

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Winfried Meissner, Prof. Dr.

CONTACT

[email protected]

+49 3641 9323353

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Azienda Ospedaliera
  • Azienda Ospedaliera Santa Maria Degli Angeli
  • Charite University, Berlin, Germany
  • Chinese PLA General Hospital
  • County Clinical Emergency Hospital Cluj-Napoca
  • Fox Valley Orthopedic Institute
  • Fundación Santa Fe de Bogota
  • Hospital Ambroise Paré Paris
  • Hospital Son Espases
  • Hôpital Raymond Poincaré
  • Insel Gruppe AG, University Hospital Bern
  • Jena University Hospital
  • Landspitali University Hospital
  • Luzerner Kantonsspital
  • Military Medical Academy, Belgrade, Serbia
  • Parc de Salut Mar
  • Rambam Health Care Campus
  • St. Luke's Medical Center
  • Takwa GmbH
  • Tel-Aviv Sourasky Medical Center
  • University Hospital Muenster
  • University Hospital, Geneva
  • University Hospital, Saarland
  • University Hospitals Coventry and Warwickshire NHS Trust
  • University Medical Center Groningen
  • University Medical Center Nijmegen
  • University of Basel
  • University of Bern
  • University of Campania Luigi Vanvitelli
  • University of Exeter
  • University of Lausanne Hospitals
  • University of Leipzig
  • University of London
  • Vrije Universiteit Brussel
  • Wuhan TongJi Hospital

Registry information

Official study title

Improvement in Postoperative Pain Outcome

Acronym: PAIN-OUT

Important dates

Study start
2009
Primary completion
2030
Study completion
2030
First posted
Mar 11, 2014
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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