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Trial record 2 of 5 for:    pain out

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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Prof. Dr. Winfried Meissner, University of Jena
Sponsor:
Collaborators:
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
Spitalul Clinic Judetean de Urgenta 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
Na Homolce Hospital
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
Klinik Hirslanden, Zurich
King Hussein Cancer Center
University of California, San Francisco
Information provided by (Responsible Party):
Prof. Dr. Winfried Meissner, University of Jena
ClinicalTrials.gov Identifier:
NCT02083835
First received: March 3, 2014
Last updated: September 13, 2017
Last verified: September 2017
  Purpose
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
Post-operative Pain

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Improvement in Postoperative Pain Outcome

Further study details as provided by Prof. Dr. Winfried Meissner, University of Jena:

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

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200000
Actual Study Start Date: January 2009
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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,l user-friendly system to improve treatment of patients with postoperative pain. A web-based information system, featuring three 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
  3. a clinical decision support system which retrieves on request cases from the registry similar to individual clinical decision situations
  Eligibility

Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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
Spitalul Clinic Judetean de Urgenta 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
Na Homolce Hospital
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
Klinik Hirslanden, Zurich
King Hussein Cancer Center
University of California, San Francisco
Investigators
Study Director: Winfried Meissner, Prof. University of Jena
  More Information

Additional Information:
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
Study First Received: March 3, 2014
Last Updated: September 13, 2017

Keywords provided by Prof. Dr. Winfried Meissner, University of Jena:
post-operative pain

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

ClinicalTrials.gov processed this record on September 18, 2017