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Trial record 2 of 10 for:    pain out

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

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ClinicalTrials.gov Identifier: NCT02083835
Recruitment Status : Recruiting
First Posted : March 11, 2014
Last Update Posted : May 24, 2018
Sponsor:
Collaborators:
Jena University Hospital
University of Exeter
University of Leipzig
Region Örebro County
Takwa GmbH
University of Basel
Parc de Salut Mar
University Hospital Muenster
Charite University, Berlin, Germany
County Clinical Emergency Hospital Cluj-Napoca
University of London
Luzerner Kantonsspital
Hôpital Raymond Poincaré
Azienda Ospedaliera Santa Maria Degli Angeli
Tel-Aviv Sourasky Medical Center
Mälardalens Högskola Västeras
University Hospital, Saarland
University Hospital Inselspital, Berne
University of Zurich
University of Bern
University Hospital, Geneva
University of Lausanne Hospitals
Fox Valley Orthopedic Institute
Landspitali University Hospital
University of Wisconsin, Madison
University of Washington
St. Luke's Medical Center
King Hussein Cancer Center
University of California, San Francisco
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rambam Health Care Campus
Fundación Santa Fe de Bogota
University Hospitals Coventry and Warwickshire NHS Trust
Chinese PLA General Hospital
Wuhan TongJi Hospital
University Medical Center Nijmegen
Military Medical Academy, Belgrade, Serbia
Hospital Ambroise Paré Paris
Vrije Universiteit Brussel
Hospital Son Espases
Azienda Ospedaliera
University of Campania "Luigi Vanvitelli"
Information provided by (Responsible Party):
Prof. Dr. Winfried Meissner, 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.

Condition or disease
Post-operative 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.

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Improvement in Postoperative Pain Outcome
Actual Study Start Date : January 2009
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2030

Group/Cohort
post-surgical patients
post-surgical patients > 18 years
pediatric patients post-op day 1
pediatric patients > 4 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant)



Primary Outcome Measures :
  1. Assessment of postoperative pain treatment [ Time Frame: first postoperative day ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult post-surgical patients in hospitals on post-op day 1
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083835


Contacts
Contact: Winfried Meissner, Prof. Dr. +49 3641 9323353 winfried.meissner@med.uni-jena.de

Locations
Germany
Jena University Hospital Recruiting
Jena, Germany, 07747
Contact: Winfried Meissner, Prof.    +49 3641 9323353      
Sponsors and Collaborators
University of Jena
Jena University Hospital
University of Exeter
University of Leipzig
Region Örebro County
Takwa GmbH
University of Basel
Parc de Salut Mar
University Hospital Muenster
Charite University, Berlin, Germany
County Clinical Emergency Hospital Cluj-Napoca
University of London
Luzerner Kantonsspital
Hôpital Raymond Poincaré
Azienda Ospedaliera Santa Maria Degli Angeli
Tel-Aviv Sourasky Medical Center
Mälardalens Högskola Västeras
University Hospital, Saarland
University Hospital Inselspital, Berne
University of Zurich
University of Bern
University Hospital, Geneva
University of Lausanne Hospitals
Fox Valley Orthopedic Institute
Landspitali University Hospital
University of Wisconsin, Madison
University of Washington
St. Luke's Medical Center
King Hussein Cancer Center
University of California, San Francisco
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rambam Health Care Campus
Fundación Santa Fe de Bogota
University Hospitals Coventry and Warwickshire NHS Trust
Chinese PLA General Hospital
Wuhan TongJi Hospital
University Medical Center Nijmegen
Military Medical Academy, Belgrade, Serbia
Hospital Ambroise Paré Paris
Vrije Universiteit Brussel
Hospital Son Espases
Azienda Ospedaliera
University of Campania "Luigi Vanvitelli"
Investigators
Study Director: Winfried Meissner, Prof. University of Jena

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Winfried Meissner, apl. Prof. Dr. med. Winfried Meissner, University of Jena
ClinicalTrials.gov Identifier: NCT02083835     History of Changes
Other Study ID Numbers: FP7 223590
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

Keywords provided by Prof. Dr. Winfried Meissner, University of Jena:
post-operative pain
paitent reported outcomes
quality improvement

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms