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Recruiting NCT02083835

PAIN OUT: Improvement in Postoperative PAIN OUTcome

— Observational Post-operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Post-operative Pain. Basic parameters: from 4 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Improvement in Postoperative Pain Outcome

Overview

PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

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.

Primary outcome measures

  • Assessment of postoperative pain treatment [Time frame: first postoperative day]
Secondary outcome measures (1)
  • patients' perception of pain treatment outcome [Time frame: first postoperative day]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Jena University Hospital — Jena

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. PMID 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) questionn PMID 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. PMID 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. PMID 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. PMID 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. PMID 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 1 PMID 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. PMID 25132607

Identifiers

NCT: NCT02083835 · FP7 223590

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗