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

NCT01467102 | Completed

• 1 other identifier: euCPSP PAIN-OUT
• Study Type: observational
• Target: 3,618
• Locations: 11 countries
• Sites: 24

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?

Conditions

Chronic Postoperative Pain

Keywords

chronic post surgical pain; Pain; Risk factors of chronic post surgical pain; predictive risk factors; chronic post-surgical pain (CPSP); international level; epidemiology of CPSP; Europe; observational; prospective

Outcome Measures

Primary Outcomes (1)

• The incidence of chronic post surgical pain (CPSP)12 months after surgery

  All patients will be asked to fill the Brief Pain Inventory (BPI) and questionnaires, at 12 months after surgery. They will do it directly on a dedicated website.

  12 months

Secondary Outcomes (2)

• Incidence of chronic post surgical pain (CPSP) 6 months after surgery

  6 months

• risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia

  12 months

Study Arms (1)

Patients

\> 18 years of age

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient 18 years old and above Patient from European centres Patient able to fill in questionnaire on his\\her own, unaided (for exception see protocol) 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). Patient has not undergone repeat surgery (same organ) during current hospitalization. Patient has undergone a surgery included in the list of surgeries(see list in eligibility criteria)

You may qualify if:

• 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
• Thoracotomy for lung cancer
• Breast surgery for cancer
• Inguinal hernia repair (laparoscopic)
• Hysterectomy (laparoscopic)
• Hysterectomy (open)
• Hysterectomy (vaginal)

Sponsors & Collaborators

• European Society of Anaesthesiology: lead
• University of Jena: collaborator

Study Sites (24)

Clinique Universitaire de St Luc

Brussels, 1200, Belgium

Location

UZA, University Hospital Of Antwerp

Edegem, 2650, Belgium

Location

Hopital Raymond Poincare

Garches, 93380, France

Location

University Hospital Jena

Jena, 07749, Germany

Location

University Hospital Münster UKM

Münster, 48149, Germany

Location

University of Wuerzburg

Würzburg, 97080, Germany

Location

Cork University Hospital

Cork, C1, Ireland

Location

Policlinico "Oo. Riuniti"

Foggia, 71100, Italy

Location

Ii Universita Di Napoli (Policlinico)

Napoli, 80138, Italy

Location

National Centre of Emergency Medicine

Chisinau, 2004, Moldova

Location

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

Bucharest, 022328, Romania

Location

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

Bucharest, 70000, Romania

Location

Hospital Universitario de San Juan

Alicante, 3550, Spain

Location

Hospital Del Mar

Barcelona, 08003, Spain

Location

Inselspital Universitätsklinikum

Bern, 3010, Switzerland

Location

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

Lausanne University Hospital

Lausanne, 1005, Switzerland

Location

Ensemble Hospitalier de la Cote in Morges

Morges, 1110, Switzerland

Location

Stadtspital Triemli

Zurich, 8063, Switzerland

Location

National Cancer Institute

Kiev, 03022, Ukraine

Location

City Clinical Hospital

Kyiv, 1133, Ukraine

Location

Zhitomir Regional Oncological centre

Zhytomyr, 10009, Ukraine

Location

Torbay Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

Location

University College Hospital NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 21544026 BACKGROUND

• 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.

  PMID: 26241763 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.

  PMID: 25503525 DERIVED

Related Links

• PAIN OUT INTERNATIONAL website

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Esther Pogatzki-Zahn, MD

  University Hospital Münster UKM, Munster

  PRINCIPAL INVESTIGATOR

• Ruth Zaslansky, MD

  Friedrich Schiller University Jena, Germany

  PRINCIPAL INVESTIGATOR

• Winfried Meissner, MD

  Friedrich Schiller University Jena, Germany

  PRINCIPAL INVESTIGATOR

• Dominique Fletcher, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 8, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 17, 2014

Record last verified: 2014-07

Locations

IE (1); UA (3); IT (2); ES (2); MO (1); CH (5); RO (2); GB (2); DE (3); BE (2); FR (1)