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RecruitingNCT02083835PAIN-OUTUpdated May 6, 2026

PAIN OUT: Improvement in Postoperative PAIN OUTcome

An observational study in Post-operative Pain, sponsored by University of Jena. Recruiting at 1 site in Germany. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Jena · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200,000
Ages
4 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Post-operative Pain

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Keywords

  • post-operative pain
  • paitent reported outcomes
  • quality improvement
03

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200,000 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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)

05

What researchers measure

Primary outcomes

  1. Assessment of postoperative pain treatment

    Time frame: first postoperative day

Secondary outcomes

  1. 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

    Time frame: first postoperative day

06

Study locations

1 of 1 sites recruiting
  • Jena University Hospital
    Jena, 07747, Germany
    • Winfried Meissner, Prof. · Contact · +49 3641 9323353
    Recruiting
07

References and documents

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. PubMed 24356102 ↗
  • 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, 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. PubMed 24021577 ↗
  • 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. PubMed 23392233 ↗
  • 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. PubMed 21724620 ↗
  • 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. PubMed 23369928 ↗
  • 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. PubMed 23279591 ↗
  • 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 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. PubMed 22337250 ↗
  • 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 Pain. 2015 Apr;19(4):490-502. doi: 10.1002/ejp.571. Epub 2014 Aug 12. PubMed 25132607 ↗
  • 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. 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. PubMed 24986116 ↗
  • 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.2017.05.006. Epub 2017 Jun 12. PubMed 28619696 ↗
  • 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. PubMed 31341822 ↗
  • 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):e0253147. doi: 10.1371/journal.pone.0253147. eCollection 2021. PubMed 34320012 ↗
  • 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, Zaslansky R. Towards Better Perioperative Pain Management in Mexico: A Study in a Network of Hospitals Using Quality Improvement Methods from PAIN OUT. J Pain Res. 2021 Feb 15;14:415-430. doi: 10.2147/JPR.S282850. eCollection 2021. PubMed 33623424 ↗
  • 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. PubMed 34731245 ↗
  • 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(3):407-415. doi: 10.1016/j.bja.2022.04.030. Epub 2022 Jun 19. PubMed 35732539 ↗
  • 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: 10.1097/j.pain.0000000000002653. Epub 2022 Apr 19. PubMed 35442934 ↗
  • Harnik MA, Oswald O, Huber M, Hofer DM, Komann M, Dreiling J, Stamer UM. Multidimensional pain assessment and opioid use after total knee arthroplasty: continuous vs single-injection regional vs systemic analgesia. Pain Rep. 2025 Mar 18;10(2):e1257. doi: 10.1097/PR9.0000000000001257. eCollection 2025 Apr. PubMed 40109369 ↗
  • Hofer DM, Harnik M, Lehmann T, Stuber F, Baumbach P, Dreiling J, Meissner W, Stamer UM. Trajectories of pain and opioid use up to one year after surgery: analysis of a European registry. Br J Anaesth. 2024 Mar;132(3):588-598. doi: 10.1016/j.bja.2023.12.002. Epub 2024 Jan 10. PubMed 38212183 ↗
  • Bernhart K, Becke-Jakob K, Lehmann T, Harnik M, Seiler S, Meissner W, Stuber F, Stamer UM. Analgesic use and favourable patient-reported outcome measures after paediatric surgery: an analysis of registry data. Br J Anaesth. 2023 Jan;130(1):74-82. doi: 10.1016/j.bja.2022.09.028. Epub 2022 Dec 5. PubMed 36470745 ↗
  • Jiang B, Wu Y, Wang X, Gan Y, Wei P, Mi W, Feng Y. The influence of involving patients in postoperative pain treatment decisions on pain-related patient-reported outcomes: A STROBE-compliant registering observational study. Medicine (Baltimore). 2022 Sep 23;101(38):e30727. doi: 10.1097/MD.0000000000030727. PubMed 36197159 ↗
  • Polanco-Garcia M, Granero R, Gallart L, Garcia-Lopez J, Montes A. Finding the vulnerable postoperative population: A two-step cluster analysis of the PAIN-OUT registry. Eur J Pain. 2022 Sep;26(8):1732-1745. doi: 10.1002/ejp.1997. Epub 2022 Jul 7. PubMed 35762292 ↗
  • Zaslansky R, Meissner W, Chapman CR. Pain after orthopaedic surgery: differences in patient reported outcomes in the United States vs internationally. An observational study from the PAIN OUT dataset. Br J Anaesth. 2018 Apr;120(4):790-797. doi: 10.1016/j.bja.2017.11.109. Epub 2018 Feb 2. PubMed 29576119 ↗
  • 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. PubMed 25503525 ↗

Related links

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Registry details

Key details

Study ID
NCT02083835
Lead sponsor
University of Jena
Collaborators
Jena University Hospital, University of Exeter, University of Leipzig, 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, University Hospital, Saarland, Insel Gruppe AG, University Hospital Bern, University of Bern, University Hospital, Geneva, University of Lausanne Hospitals, Fox Valley Orthopedic Institute, Landspitali University Hospital, St. Luke's Medical Center, 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, University Medical Center Groningen
Responsible party
Prof. Dr. Winfried Meissner (apl. Prof. Dr. med. Winfried Meissner, University of Jena) — Principal investigator
First posted
Mar 11, 2014
Start date
Jan 2009
Primary completion
Dec 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
May 6, 2026

Study contacts

Winfried Meissner, Prof. Dr.
Contact
winfried.meissner@med.uni-jena.de
+49 3641 9323353
Winfried Meissner, Prof.
study director · University of Jena

Oversight

Data monitoring committee
No
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