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

Chronic Postoperative Pain Clinical Trial

— PAIN-OUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467102
• Other study ID #: euCPSP PAIN-OUT
• Status: Completed
• Phase: N/A
• First received: November 4, 2011
• Last updated: July 16, 2014
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3618
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Pain, Postoperative

Locations

Country	Name	City	State
Belgium	Clinique Universitaire de St Luc	Bruxelles
Belgium	UZA, University Hospital Of Antwerp	Edegem
France	Hopital Raymond Poincare	Garches
Germany	University Hospital Jena	Jena
Germany	University Hospital Münster UKM	Münster
Germany	University of Wuerzburg	Würzburg
Ireland	Cork University Hospital	Cork
Italy	Policlinico "Oo. Riuniti"	Foggia
Italy	Ii Universita Di Napoli (Policlinico)	Napoli
Moldova, Republic of	National Centre of Emergency Medicine	Chisinau
Romania	Central Universitty and Emergency Military Hospital "Dr. Carol Davila"	Bucharest
Romania	Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''	Bucharest
Spain	Hospital Universitario de San Juan	Alicante
Spain	Hospital Del Mar	Barcelona
Switzerland	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	Zürich
Ukraine	National Cancer Institute	Kiev
Ukraine	City Clinical Hospital	Kyiv
Ukraine	Zhitomir Regional Oncological centre	Zhitomir
United Kingdom	University College Hospital NHS Foundation Trust	London
United Kingdom	Torbay Hospital	Torquay	Devon

Sponsors (2)

Lead Sponsor	Collaborator
European Society of Anaesthesiology	University of Jena

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Ireland,  Italy,  Moldova, Republic of,  Romania,  Spain,  Switzerland,  Ukraine,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia		12 months	No

External Links

•   European Society of Anaesthesiology Website Info on the study
•   PAIN OUT INTERNATIONAL website