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

Sponsor

European Society of Anaesthesiology (Other)

Overall Status

Completed

CT.gov ID

NCT01467102

Collaborator

University of Jena (Other)

3,618

Enrollment

Locations

Duration (Months)

150.8

Patients Per Site

5.2

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

3618 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Patients > 18 years of age

Outcome Measures

Primary Outcome Measures

The incidence of chronic post surgical pain (CPSP)12 months after surgery [12 months]
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.

Secondary Outcome Measures

Incidence of chronic post surgical pain (CPSP) 6 months after surgery [6 months]
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.
risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Thoracotomy for lung cancer
Breast surgery for cancer
Inguinal hernia repair (laparoscopic)
Hysterectomy (laparoscopic)
Hysterectomy (open)
Hysterectomy (vaginal)
Colectomy (laparoscopic)
Colectomy (open)
Thyroidectomy
C section
High gastric bypass
Laparoscopy
Prostatectomy

Surgery with potential preoperative pain

Cholecystectomy (laparoscopic)
Cholecystectomy (open)
Total knee arthroplasty
Knee arthroscopy
Total hip arthroplasty
Extracorporeal circulation auxiliary to open heart surgery
Spinal surgery
Hip arthrotomy

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Universitaire de St Luc	Bruxelles		Belgium	1200
2	UZA, University Hospital Of Antwerp	Edegem		Belgium	2650
3	Hopital Raymond Poincare	Garches		France	93380
4	University Hospital Jena	Jena		Germany	07749
5	University Hospital Münster UKM	Münster		Germany	48149
6	University of Wuerzburg	Würzburg		Germany	97080
7	Cork University Hospital	Cork		Ireland	C1
8	Policlinico "Oo. Riuniti"	Foggia		Italy	71100
9	Ii Universita Di Napoli (Policlinico)	Napoli		Italy	80138
10	National Centre of Emergency Medicine	Chisinau		Moldova, Republic of	2004
11	Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''	Bucharest		Romania	022328
12	Central Universitty and Emergency Military Hospital "Dr. Carol Davila"	Bucharest		Romania	70000
13	Hospital Universitario de San Juan	Alicante		Spain	3550
14	Hospital Del Mar	Barcelona		Spain	08003
15	Inselspital Universitätsklinikum	Bern		Switzerland	3010
16	Hôpitaux Universitaires de Genève	Geneva		Switzerland	1211
17	Lausanne University Hospital	Lausanne		Switzerland	1005
18	Ensemble Hospitalier de la Cote in Morges	Morges		Switzerland	1110
19	Stadtspital Triemli	Zürich		Switzerland	8063
20	National Cancer Institute	Kiev		Ukraine	03022
21	City Clinical Hospital	Kyiv		Ukraine	1133
22	Zhitomir Regional Oncological centre	Zhitomir		Ukraine	10009
23	Torbay Hospital	Torquay	Devon	United Kingdom	TQ2 7AA
24	University College Hospital NHS Foundation Trust	London		United Kingdom	NW1 2BU

Sponsors and Collaborators

European Society of Anaesthesiology
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