Chronic Postoperative PainPAIN-OUTNCT01467102
euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study
An observational study of Chronic Postoperative Pain, run by European Society of Anaesthesiology at 24 sites in 11 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Postoperative Pain
- How many people
- 3,618 participants
- Where
- 24 sitesin 11 countries
- Study dates
- Jul 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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.
Show all 31Show fewer
- 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
Who cannot join
- patient not fulfilling at least one of the inclusion criteria mentioned above
Trial locations and contacts
24 sites in 11 countries.
24 sites in 11 countries
Switzerland5 sites
Inselspital Universitätsklinikum
Bern, 3010
Hôpitaux Universitaires de Genève
Geneva, 1211
Lausanne University Hospital
Lausanne, 1005
Ensemble Hospitalier de la Cote in Morges
Morges, 1110
Stadtspital Triemli
Zurich, 8063
Germany3 sites
University Hospital Jena
Jena, 07749
University Hospital Münster UKM
Münster, 48149
University of Wuerzburg
Würzburg, 97080
Ukraine3 sites
National Cancer Institute
Kiev, 03022
City Clinical Hospital
Kyiv, 1133
Zhitomir Regional Oncological centre
Zhytomyr, 10009
Belgium2 sites
Clinique Universitaire de St Luc
Brussels, 1200
UZA, University Hospital Of Antwerp
Edegem, 2650
Italy2 sites
Policlinico "Oo. Riuniti"
Foggia, 71100
Ii Universita Di Napoli (Policlinico)
Naples, 80138
Romania2 sites
Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''
Bucharest, 022328
Central Universitty and Emergency Military Hospital "Dr. Carol Davila"
Bucharest, 70000
Spain2 sites
Hospital Universitario de San Juan
Alicante, 3550
Hospital Del Mar
Barcelona, 08003
United Kingdom2 sites
University College Hospital NHS Foundation Trust
London, NW1 2BU
Torbay Hospital
Torquay, Devon, TQ2 7AA
About this study
Official title: euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT
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?
Read the 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.
- Conditions
- Chronic Postoperative Pain
- Keywords
- 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
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | > 18 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 6 months
risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Jena
- Responsible party
- Sponsor
- Investigators
- Esther Pogatzki-Zahn, MD, Principal investigator, University Hospital Münster UKM, MunsterRuth Zaslansky, MD, Principal investigator, University of JenaWinfried Meissner, MD, Principal investigator, University of JenaDominique Fletcher, MD, Study chair, Hôpital Raymond Poincaré AP-HP,Université Versailles St Quentin,Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467102
- Sponsor's protocol ID
- euCPSP PAIN-OUT
- Acronym
- PAIN-OUT
- Status last verified
- Jul 2014
- First submitted
- 4 Nov 2011
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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. No abstract available.
PubMed 21544026Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.
PubMed 26241763Stamer UM, Naef N, Porz R, Stuber F, Leva B, Meissner W, Fletcher D; euCPSP Study Group. Ethical procedures and patient consent differ in Europe. Eur J Anaesthesiol. 2015 Feb;32(2):126-31. doi: 10.1097/EJA.0000000000000206.
PubMed 25503525
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT
- ClinicalTrials.gov ID
- NCT01467102
- Acronym / sponsor ID
- PAIN-OUT / euCPSP PAIN-OUT
- Conditions
- Chronic Postoperative Pain
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,618 participants (actual)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Collaborators
- University of Jena
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –> 18 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (31 listed)
- 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.
Key exclusion criteria (1 listed)
- patient not fulfilling at least one of the inclusion criteria mentioned above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Incidence of chronic post surgical pain (CPSP) 6 months after surgery
Time frame: 6 months
risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Background: PubMed 21544026Fletcher 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. No abstract available.
- Derived from this study: PubMed 26241763Fletcher D, Stamer UM, Pogatzki-Zahn E, Zaslansky R, Tanase NV, Perruchoud C, Kranke P, Komann M, Lehman T, Meissner W; euCPSP group for the Clinical Trial Network group of the European Society of Anaesthesiology. Chronic postsurgical pain in Europe: An observational study. Eur J Anaesthesiol. 2015 Oct;32(10):725-34. doi: 10.1097/EJA.0000000000000319.
- Derived from this study: PubMed 25503525Stamer UM, Naef N, Porz R, Stuber F, Leva B, Meissner W, Fletcher D; euCPSP Study Group. Ethical procedures and patient consent differ in Europe. Eur J Anaesthesiol. 2015 Feb;32(2):126-31. doi: 10.1097/EJA.0000000000000206.
- PAIN OUT INTERNATIONAL websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther Pogatzki-Zahn, MD principal investigator
University Hospital Münster UKM, Munster
Ruth Zaslansky, MD principal investigator
University of Jena
Winfried Meissner, MD principal investigator
University of Jena
24 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Postoperative Pain, run by European Society of Anaesthesiology at 24 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Switzerland, Germany, Ukraine, Belgium, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chronic post surgical pain (CPSP)12 months after surgery (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.