PAIN OUT: Improvement in Postoperative PAIN OUTcome (PAIN-OUT)

May 9, 2023 updated by: Prof. Dr. Winfried Meissner, University of Jena

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Jena, Germany, 07747
        • Recruiting
        • Jena University Hospital
        • Contact:
          • Winfried Meissner, Prof.
          • Phone Number: +49 3641 9323353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

adult post-surgical patients in hospitals on post-op day 1

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
post-surgical patients
post-surgical patients > 18 years
pediatric patients post-op day 1
pediatric patients <18 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of postoperative pain treatment
Time Frame: first postoperative day
first postoperative day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
first postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

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

Investigators

  • Study Director: Winfried Meissner, Prof., University of Jena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP7 223590

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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