PAIN OUT: Improvement in Postoperative PAIN OUTcome

Post-operative Pain Clinical Trial

— PAIN-OUT  

Official title:

Improvement in Postoperative Pain Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02083835
• Other study ID #: FP7 223590
• Status: Recruiting
• Start date: January 2009
• Est. completion date: December 2030

Study information

• Verified date: May 2023
• Source: University of Jena
• Contact: Winfried Meissner, Prof. Dr.
• Phone: +49 3641 9323353
• Email: winfried.meissner[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Locations

Country	Name	City	State
Germany	Jena University Hospital	Jena

Sponsors (40)

Lead Sponsor

Collaborator

University of Jena

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

Country where clinical trial is conducted

Germany, 

References & Publications (16)

Dubljanin Raspopovic E, Meissner W, Zaslansky R, Kadija M, Tomanovic Vujadinovic S, Tulic G. Associations between early postoperative pain outcome measures and late functional outcomes in patients after knee arthroplasty. PLoS One. 2021 Jul 28;16(7):e0253 — View Citation

Garduno-Lopez AL, Acosta Nava VM, Castro Garces L, Rascon-Martinez DM, Cuellar-Guzman LF, Flores-Villanueva ME, Villegas-Sotelo E, Carrillo-Torres O, Vilchis-Samano H, Calderon-Vidal M, Islas-Lagunas G, Richard Chapman C, Komann M, Meissner W, Baumbach P, — View Citation

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.0b013e318 — View Citation

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 — View Citation

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 — View Citation

Hofer DM, Lehmann T, Zaslansky R, Harnik M, Meissner W, Stuber F, Stamer UM. Rethinking the definition of chronic postsurgical pain: composites of patient-reported pain-related outcomes vs pain intensities alone. Pain. 2022 Dec 1;163(12):2457-2465. doi: 1 — View Citation

Komann M, Weinmann C, Schwenkglenks M, Meissner W. Non-Pharmacological Methods and Post-Operative Pain Relief: An Observational Study. Anesth Pain Med. 2019 Apr 20;9(2):e84674. doi: 10.5812/aapm.84674. eCollection 2019 Apr. — View Citation

Polanco-Garcia M, Garcia-Lopez J, Fabregas N, Meissner W, Puig MM; PAIN-OUT-Spain Consortium. Postoperative Pain Management in Spanish Hospitals: A Cohort Study Using the PAIN-OUT Registry. J Pain. 2017 Oct;18(10):1237-1252. doi: 10.1016/j.jpain.2017.05.0 — View Citation

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. — View Citation

Rothaug J, Zaslansky R, Schwenkglenks M, Komann M, Allvin R, Backstrom 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, Ya — View Citation

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) — View Citation

van Dijk JFM, Zaslansky R, van Boekel RLM, Cheuk-Alam JM, Baart SJ, Huygen FJPM, Rijsdijk M. Postoperative Pain and Age: A Retrospective Cohort Association Study. Anesthesiology. 2021 Dec 1;135(6):1104-1119. doi: 10.1097/ALN.0000000000004000. — View Citation

van Driel MEC, van Dijk JFM, Baart SJ, Meissner W, Huygen FJPM, Rijsdijk M. Development and validation of a multivariable prediction model for early prediction of chronic postsurgical pain in adults: a prospective cohort study. Br J Anaesth. 2022 Sep;129( — View Citation

Zaslansky R, Chapman CR, Rothaug J, Backstrom 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 — View Citation

Zaslansky R, Rothaug J, Chapman CR, Backstrom 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 P — View Citation

Zaslansky R, Rothaug J, Chapman RC, Backstrom 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of postoperative pain treatment		first postoperative day
Secondary	patients' perception of pain treatment outcome	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

External Links

•   Project webpage