Clinical trial NCT01467102: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study
Official title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
Collaborators: name: University of Jena
First posted: 2011-11-08
Enrollment: 3618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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

Exclusion Criteria:

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

Primary outcomes:
measure: The incidence of chronic post surgical pain (CPSP)12 months after surgery
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of chronic post surgical pain (CPSP) 6 months after surgery
timeFrame: 6 months
measure: risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia
timeFrame: 12 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique Universitaire de St Luc
city: Edegem
country: Belgium
facility: UZA, University Hospital Of Antwerp
city: Garches
country: France
facility: Hopital Raymond Poincare
city: Jena
country: Germany
facility: University Hospital Jena
city: Münster
country: Germany
facility: University Hospital Münster UKM
city: Würzburg
country: Germany
facility: University of Wuerzburg
city: Cork
country: Ireland
facility: Cork University Hospital
city: Foggia
country: Italy
facility: Policlinico "Oo. Riuniti"
city: Napoli
country: Italy
facility: Ii Universita Di Napoli (Policlinico)
city: Chisinau
country: Moldova, Republic of
facility: National Centre of Emergency Medicine
city: Bucharest
country: Romania
facility: Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''
city: Bucharest
country: Romania
facility: Central Universitty and Emergency Military Hospital "Dr. Carol Davila"
city: Alicante
country: Spain
facility: Hospital Universitario de San Juan
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Bern
country: Switzerland
facility: Inselspital Universitätsklinikum
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
city: Morges
country: Switzerland
facility: Ensemble Hospitalier de la Cote in Morges
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
city: Kiev
country: Ukraine
facility: National Cancer Institute
city: Kyiv
country: Ukraine
facility: City Clinical Hospital
city: Zhitomir
country: Ukraine
facility: Zhitomir Regional Oncological centre
city: Torquay
country: United Kingdom
facility: Torbay Hospital
state: Devon
city: London
country: United Kingdom
facility: University College Hospital NHS Foundation Trust
Study officials:
affiliation: University Hospital Münster UKM, Munster
name: Esther Pogatzki-Zahn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich Schiller University Jena, Germany
name: Ruth Zaslansky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich Schiller University Jena, Germany
name: Winfried Meissner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Raymond Poincaré AP-HP,Université Versailles St Quentin,Garches, France
name: Dominique Fletcher, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.