euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study

NCT ID: NCT01467102

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3618 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-12-31

Brief Summary

This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

• What is the incidence of chronic post surgical pain (CPSP) in Europe?
• What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
• What are the difference in incidence and risk factors in different European countries?

Detailed Description

The main goal of the study is to obtain a generalizable epidemiology of chronic post surgical pain (CPSP) by performing a large data collection in many European countries. The large sample will allow analysis of the incidence of CPSP, differences in incidence patterns in Europe, incidence in rare types of surgeries and specific populations. This observational, prospective study will help to better anticipate and potentially prevent the development of chronic post surgical pain (CPSP). In fact when CPSP occurs patients are frequently undiagnosed and pain is poorly managed such that patients may develop refractory chronic pain. Surgery is a major cause of chronic pain and it is unique in that there is potential to prevent it from occurring. Data from this study might alert respectively surgeons and anesthetists about the most important types of surgery and some perioperative techniques of pain prevention with an impact on the incidence of chronic post surgical pain(CPSP). Anesthesiologists, who are leading this project, might therefore, have an important role in preventing future cases of chronic post surgical pain (CPSP).

Sample size calculation:

The investigators expect that at least 30 sites will be able to participate and recruit 200 patients a year, to a maximum of 6,000 patients, over the one year study period. Since the mean incidence of CPSP is approximately 30%, this will offer an estimated potential number of 2000 patients with CPSP.

Organisation:

Investigators will use questionnaire in English, German, French, Spanish, Italian, Romanian, Swedish, Hebrew, Dutch and Russian. They will supervise data collection, ensure timely data return and act as guarantor for the integrity and quality of data collected.

The Chief investigator, Professor Fletcher is a member of the PAIN OUT group and will closely work with the new group of investigators participating in the project on CPSP. His experience with the European PAIN OUT project will be very valuable to organize and coordinate the study. The European Society of Anaesthesiology (ESA) is supporting this project and will help with administrative coordination to build the European network.

Time scale:

The study will last two and a half years with one year for recruitment, one year for follow up and 6 months for analysis.

Statistical Analysis:

Incidence of chronic post surgical pain (CPSP) at 12 months for all types of surgeries analyzed will be expressed as mean and confidence interval 95%. The investigators will compare the incidence in various types of surgeries, different centres and countries.

Risk factors of chronic post surgical pain (CPSP) will be analyzed using univariate and multivariate analysis. The most predictive factors will be chosen by fitting a logistic regression model using a forward selection procedure. By combining data from different centres, the investigators will determine most significant risk factors.

Conditions

Chronic Postoperative Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

\> 18 years of age

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient 18 years old and above
• Patient has given consent
• Patient is able to fill in questionnaire on his\her own, unaided (exceptions are patients who are unable to fill in the questionnaire for technical reasons, e.g. can not write due to the surgery (e.g. their arm in a cast) or unable to see the text (e.g. spectacles not available); patient is in department, available for interview.
• Patient is capable of participating in the CPSP incidence study (i.e. capable to fill the questionnaires on the website at 6 and 12 months after surgery).
• Time of data collection immediately after surgery is POD1 and 24±12 hrs after surgery.
• Patient has not undergone repeat surgery (same organ) during current hospitalization.
• Patient has undergone a surgery included in the appendix 1 list below:

List of surgeries to be included:

Surgery without preoperative pain

1. Thoracotomy for lung cancer

2. Breast surgery for cancer

3. Inguinal hernia repair (laparoscopic)

4. Hysterectomy (laparoscopic)

5. Hysterectomy (open)

6. Hysterectomy (vaginal)

7. Colectomy (laparoscopic)

8. Colectomy (open)

9. Thyroidectomy

10. C section

11. High gastric bypass

12. Laparoscopy

13. Prostatectomy

Surgery with potential preoperative pain

1. Cholecystectomy (laparoscopic)

2. Cholecystectomy (open)

3. Total knee arthroplasty

4. Knee arthroscopy

5. Total hip arthroplasty

6. Extracorporeal circulation auxiliary to open heart surgery

7. Spinal surgery

8. Hip arthrotomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jena

OTHER

Sponsor Role: collaborator

European Society of Anaesthesiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Pogatzki-Zahn, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Münster UKM, Munster

Ruth Zaslansky, MD

Role: PRINCIPAL_INVESTIGATOR

Friedrich Schiller University Jena, Germany

Winfried Meissner, MD

Role: PRINCIPAL_INVESTIGATOR

Friedrich Schiller University Jena, Germany

Dominique Fletcher, MD

Role: STUDY_CHAIR

Hôpital Raymond Poincaré AP-HP,Université Versailles St Quentin,Garches, France

Locations

Clinique Universitaire de St Luc

Brussels, , Belgium

UZA, University Hospital Of Antwerp

Edegem, , Belgium

Hopital Raymond Poincare

Garches, , France

University Hospital Jena

Jena, , Germany

University Hospital Münster UKM

Münster, , Germany

University of Wuerzburg

Würzburg, , Germany

Cork University Hospital

Cork, , Ireland

Policlinico "Oo. Riuniti"

Foggia, , Italy

Ii Universita Di Napoli (Policlinico)

Napoli, , Italy

National Centre of Emergency Medicine

Chisinau, , Moldova

Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''

Bucharest, , Romania

Central Universitty and Emergency Military Hospital "Dr. Carol Davila"

Bucharest, , Romania

Hospital Universitario de San Juan

Alicante, , Spain

Hospital Del Mar

Barcelona, , Spain

Inselspital Universitätsklinikum

Bern, , Switzerland

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Lausanne University Hospital

Lausanne, , Switzerland

Ensemble Hospitalier de la Cote in Morges

Morges, , Switzerland

Stadtspital Triemli

Zurich, , Switzerland

National Cancer Institute

Kiev, , Ukraine

City Clinical Hospital

Kyiv, , Ukraine

Zhitomir Regional Oncological centre

Zhytomyr, , Ukraine

Torbay Hospital

Torquay, Devon, United Kingdom

University College Hospital NHS Foundation Trust

London, , United Kingdom

Countries

Belgium; France; Germany; Ireland; Italy; Moldova; Romania; Spain; Switzerland; Ukraine; United Kingdom

References

Fletcher D, Pogatzki-Zahn E, Zaslansky R, Meissner W; Pain Out Group. euCPSP: European observational study on chronic post-surgical pain. Eur J Anaesthesiol. 2011 Jun;28(6):461-2. doi: 10.1097/EJA.0b013e328344b4cd. No abstract available.

Reference Type: BACKGROUND

PMID: 21544026 (View on PubMed)

Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.

Reference Type: DERIVED

PMID: 26241763 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25503525 (View on PubMed)

Related Links

http://www.pain-out.eu/

PAIN OUT INTERNATIONAL website

Other Identifiers

euCPSP PAIN-OUT

Identifier Type: -

Identifier Source: org_study_id