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

This study has been completed.
Sponsor:
Collaborator:
University of Jena
Information provided by (Responsible Party):
European Society of Anaesthesiology
ClinicalTrials.gov Identifier:
NCT01467102
First received: November 4, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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
Chronic Postoperative Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT

Further study details as provided by European Society of Anaesthesiology:

Primary Outcome Measures:
  • The incidence of chronic post surgical pain (CPSP)12 months after surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 3618
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients
> 18 years of age

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467102

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

Additional Information:
Publications:
Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01467102     History of Changes
Other Study ID Numbers: euCPSP PAIN-OUT
Study First Received: November 4, 2011
Last Updated: July 16, 2014
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by European Society of Anaesthesiology:
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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014