Know Cancer

forgot password

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

18 Years
Open (Enrolling)
Chronic Postoperative Pain

Thank you

Trial Information

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

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.


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.

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

- 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

4. Hysterectomy

5. Colectomy

6. Appendectomy

Surgery with potential preoperative pain

1. Cholecystectomy

2. Total knee arthroplasty

3. Knee arthroscopy

4. Lower limb amputation

5. Sternotomy for valve replacement or CABG

Exclusion Criteria:

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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Esther Pogatzki-Zahn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Münster UKM, Munster


France: The Commission nationale de l’informatique et des libertés

Study ID:




Start Date:

July 2011

Completion Date:

December 2013

Related Keywords:

  • Chronic Postoperative Pain
  • 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
  • Pain, Postoperative