Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01467102
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
University of Jena
Information provided by (Responsible Party):
European Society of Anaesthesiology

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
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.

Layout table for study information
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 : July 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
> 18 years of age



Primary Outcome Measures :
  1. The incidence of chronic post surgical pain (CPSP)12 months after surgery [ Time Frame: 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 :
  1. Incidence of chronic post surgical pain (CPSP) 6 months after surgery [ Time Frame: 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.

  2. risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia [ Time Frame: 12 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467102


Locations
Show Show 24 study locations
Sponsors and Collaborators
European Society of Anaesthesiology
University of Jena
Investigators
Layout table for investigator information
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
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01467102    
Other Study ID Numbers: euCPSP PAIN-OUT
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: July 2014
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:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations