PAIN OUT: Improvement in Postoperative PAIN OUTcome

NCT02083835 | Recruiting

• 1 other identifier: FP7 223590
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Keywords

post-operative pain; paitent reported outcomes; quality improvement

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative pain treatment

  first postoperative day

Secondary Outcomes (1)

• patients' perception of pain treatment outcome

  first postoperative day

Study Arms (2)

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)

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \>= 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

You may not qualify if:

• patient cannot communicate
• patient is cognitively impaired
• patient is asleep
• patient is too ill
• patient does not want to fill in the questionnaire

Sponsors & Collaborators

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

Study Sites (1)

Jena University Hospital

Jena, 07747, Germany

RECRUITING

Related Publications (23)

• 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.

  PMID: 24356102 RESULT

• 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.

  PMID: 24021577 RESULT

• 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.

  PMID: 23392233 RESULT

• 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.

  PMID: 21724620 RESULT

• 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.

  PMID: 23369928 RESULT

• 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.

  PMID: 23279591 RESULT

• 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.

  PMID: 22337250 RESULT

• 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.

  PMID: 25132607 RESULT

• 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.

  PMID: 24986116 RESULT

• 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.

  PMID: 28619696 RESULT

• 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.

  PMID: 31341822 RESULT

• 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.

  PMID: 34320012 RESULT

• 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.

  PMID: 33623424 RESULT

• 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.

  PMID: 34731245 RESULT

• 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.

  PMID: 35732539 RESULT

• 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.

  PMID: 35442934 RESULT

• 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.

  PMID: 40109369 DERIVED

• 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.

  PMID: 38212183 DERIVED

• 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.

  PMID: 36470745 DERIVED

• 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.

  PMID: 36197159 DERIVED

• 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.

  PMID: 35762292 DERIVED

• 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.

  PMID: 29576119 DERIVED

• 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.

  PMID: 25503525 DERIVED

Related Links

• Project webpage

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Winfried Meissner, Prof.

  University of Jena

  STUDY DIRECTOR

Central Study Contacts

Winfried Meissner, Prof. Dr.

CONTACT

+49 3641 9323353; winfried.meissner@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: apl. Prof. Dr. med. Winfried Meissner

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 11, 2014
• Study Start: January 1, 2009
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

DE (1)