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

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

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?

Study Overview

• Status: Completed
• Conditions: Chronic Postoperative Pain

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.

• Study Type: Observational
• Enrollment (Actual): 3618

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Clinique Universitaire de St Luc
  • Edegem, Belgium, 2650
    • UZA, University Hospital Of Antwerp
• France
  • Garches, France, 93380
    • Hôpital Raymond Poincaré
• Germany
  • Jena, Germany, 07749
    • University Hospital Jena
  • Münster, Germany, 48149
    • University Hospital Münster UKM
  • Würzburg, Germany, 97080
    • University of Wuerzburg
• Ireland
  • Cork, Ireland, C1
    • Cork University Hospital
• Italy
  • Foggia, Italy, 71100
    • Policlinico "Oo. Riuniti"
  • Napoli, Italy, 80138
    • Ii Universita Di Napoli (Policlinico)
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, 2004
    • National Centre of Emergency Medicine
• Romania
  • Bucharest, Romania, 022328
    • Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''
  • Bucharest, Romania, 70000
    • Central Universitty and Emergency Military Hospital "Dr. Carol Davila"
• Spain
  • Alicante, Spain, 3550
    • Hospital Universitario de San Juan
  • Barcelona, Spain, 08003
    • Hospital Del Mar
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Universitätsklinikum
  • Geneva, Switzerland, 1211
    • Hopitaux Universitaires de Geneve
  • Lausanne, Switzerland, 1005
    • Lausanne University Hospital
  • Morges, Switzerland, 1110
    • Ensemble Hospitalier de la Cote in Morges
  • Zürich, Switzerland, 8063
    • Stadtspital Triemli
• Ukraine
  • Kiev, Ukraine, 03022
    • National Cancer Institute
  • Kyiv, Ukraine, 1133
    • City Clinical Hospital
  • Zhitomir, Ukraine, 10009
    • Zhitomir Regional Oncological centre
• United Kingdom
  • London, United Kingdom, NW1 2BU
    • University College Hospital NHS Foundation Trust
  • Devon
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • Torbay Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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)

Description

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

Exclusion Criteria:

• patient not fulfilling at least one of the inclusion criteria mentioned above

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; > 18 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of chronic post surgical pain (CPSP) 6 months after surgery	All patients will be asked to fill the Brief Pain Inventory (BPI) and questionnaires, at 6 months after surgery. They will do it directly on a dedicated website.	6 months
risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia		12 months

Collaborators and Investigators

• Sponsor: European Society of Anaesthesiology
• Collaborators: University of Jena
• Investigators: Principal Investigator: 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; Study Chair: Dominique Fletcher, MD, Hôpital Raymond Poincaré AP-HP,Université Versailles St Quentin,Garches, France

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• PAIN OUT INTERNATIONAL website

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: November 4, 2011
• First Submitted That Met QC Criteria: November 7, 2011
• First Posted (Estimate): November 8, 2011

Study Record Updates

• Last Update Posted (Estimate): July 17, 2014
• Last Update Submitted That Met QC Criteria: July 16, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Pain; prospective; observational; Europe; chronic post surgical pain; Risk factors of chronic post surgical pain; predictive risk factors; chronic post-surgical pain (CPSP); international level; epidemiology of CPSP
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: euCPSP PAIN-OUT