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PAIN OUT: Improvement in Postoperative PAIN OUTcome

Improvement in Postoperative Pain Outcome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02083835
Acronym
PAIN-OUT
Enrollment
200000
Registered
2014-03-11
Start date
2009-01-01
Completion date
2030-12-31
Last updated
2026-05-06

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

Conditions

Post-operative Pain

Keywords

post-operative pain, paitent reported outcomes, quality improvement

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.

Interventions

None listed

Sponsors

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

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
Assessment of postoperative pain treatmentfirst postoperative day

Secondary

MeasureTime frameDescription
patients' perception of pain treatment outcomefirst 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

Countries

Germany

Contacts

CONTACTWinfried Meissner, Prof. Dr.
winfried.meissner@med.uni-jena.de+49 3641 9323353
STUDY_DIRECTORWinfried Meissner, Prof.

University of Jena

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026