Trial record 2 of 5 for: pain out

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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

History of Changes

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:

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
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:

Project webpage This link exits the ClinicalTrials.gov site

Publications:

Gerbershagen HJ, Pogatzki-Zahn E, Aduckathil S, Peelen LM, Kappen TH, van Wijck AJ, Kalkman CJ, Meissner W. Procedure-specific risk factor analysis for the development of severe postoperative pain. Anesthesiology. 2014 May;120(5):1237-45. doi: 10.1097/ALN.0000000000000108.

Rothaug J, Zaslansky R, Schwenkglenks M, Komann M, Allvin R, Backström R, Brill S, Buchholz I, Engel C, Fletcher D, Fodor L, Funk P, Gerbershagen HJ, Gordon DB, Konrad C, Kopf A, Leykin Y, Pogatzki-Zahn E, Puig M, Rawal N, Taylor RS, Ullrich K, Volk T, Yahiaoui-Doktor M, Meissner W. Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire. J Pain. 2013 Nov;14(11):1361-70. doi: 10.1016/j.jpain.2013.05.016. Epub 2013 Sep 7.

Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

Gerbershagen HJ, Rothaug J, Kalkman CJ, Meissner W. Determination of moderate-to-severe postoperative pain on the numeric rating scale: a cut-off point analysis applying four different methods. Br J Anaesth. 2011 Oct;107(4):619-26. doi: 10.1093/bja/aer195. Epub 2011 Jun 30.

Rothaug J, Weiss T, Meissner W. How simple can it get? Measuring pain with NRS items or binary items. Clin J Pain. 2013 Mar;29(3):224-32. doi: 10.1097/AJP.0b013e31824c5d7a.

Taylor RS, Ullrich K, Regan S, Broussard C, Schwenkglenks M, Taylor RJ, Gordon DB, Zaslansky R, Meissner W, Rothaug J, Langford R; PAIN-OUT investigators. The impact of early postoperative pain on health-related quality of life. Pain Pract. 2013 Sep;13(7):515-23. doi: 10.1111/papr.12026. Epub 2012 Dec 23.

Zaslansky R, Chapman CR, Rothaug J, Bäckström R, Brill S, Davidson E, Elessi K, Fletcher D, Fodor L, Karanja E, Konrad C, Kopf A, Leykin Y, Lipman A, Puig M, Rawal N, Schug S, Ullrich K, Volk T, Meissner W. Feasibility of international data collection and feedback on post-operative pain data: proof of concept. Eur J Pain. 2012 Mar;16(3):430-8. doi: 10.1002/j.1532-2149.2011.00024.x. Epub 2011 Dec 19.

Zaslansky R, Rothaug J, Chapman CR, Bäckström R, Brill S, Fletcher D, Fodor L, Gordon DB, Komann M, Konrad C, Leykin Y, Pogatski-Zahn E, Puig MM, Rawal N, Ullrich K, Volk T, Meissner W. PAIN OUT: the making of an international acute pain registry. Eur J Pain. 2015 Apr;19(4):490-502. doi: 10.1002/ejp.571. Epub 2014 Aug 12.

Zaslansky R, Rothaug J, Chapman RC, Backström R, Brill S, Engel C, Fletcher D, Fodor L, Funk P, Gordon D, Komann M, Konrad C, Kopf A, Leykin Y, Pogatzki-Zahn E, Puig M, Rawal N, Schwenkglenks M, Taylor RS, Ullrich K, Volk T, Yahiaoui-Doktor M, Meissner W. PAIN OUT: an international acute pain registry supporting clinicians in decision making and in quality improvement activities. J Eval Clin Pract. 2014 Dec;20(6):1090-8. doi: 10.1111/jep.12205. Epub 2014 Jul 1.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stamer UM, Naef N, Porz R, Stuber F, Leva B, Meissner W, Fletcher D; euCPSP Study Group. Ethical procedures and patient consent differ in Europe. Eur J Anaesthesiol. 2015 Feb;32(2):126-31. doi: 10.1097/EJA.0000000000000206. Erratum in: Eur J Anaesthesiol. 2015 Mar;32(3):222.


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

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