Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT01467102
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2011-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3618}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2011-11-04', 'studyFirstSubmitQcDate': '2011-11-07', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of chronic post surgical pain (CPSP)12 months after surgery', 'timeFrame': '12 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of chronic post surgical pain (CPSP) 6 months after surgery', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['Chronic Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '21544026', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26241763', 'type': 'DERIVED', 'citation': 'Fletcher 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.'}, {'pmid': '25503525', 'type': 'DERIVED', 'citation': 'Stamer 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.'}], 'seeAlsoLinks': [{'url': 'http://www.pain-out.eu/', 'label': 'PAIN OUT INTERNATIONAL website'}]}, 'descriptionModule': {'briefSummary': 'This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).\n\nResearch Questions\n\n* What is the incidence of chronic post surgical pain (CPSP) in Europe?\n* What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?\n* What are the difference in incidence and risk factors in different European countries?', 'detailedDescription': '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).\n\nSample size calculation:\n\nThe 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.\n\nOrganisation:\n\nInvestigators 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.\n\nThe 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.\n\nTime scale:\n\nThe study will last two and a half years with one year for recruitment, one year for follow up and 6 months for analysis.\n\nStatistical Analysis:\n\nIncidence 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.\n\nRisk 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).\n\nPatient has not undergone repeat surgery (same organ) during current hospitalization.\n\nPatient has undergone a surgery included in the list of surgeries(see list in eligibility criteria)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient 18 years old and above\n* Patient has given consent\n* 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.\n* 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).\n* Time of data collection immediately after surgery is POD1 and 24±12 hrs after surgery.\n* Patient has not undergone repeat surgery (same organ) during current hospitalization.\n* Patient has undergone a surgery included in the appendix 1 list below:\n\nList of surgeries to be included:\n\nSurgery without preoperative pain\n\n1. Thoracotomy for lung cancer\n2. Breast surgery for cancer\n3. Inguinal hernia repair (laparoscopic)\n4. Hysterectomy (laparoscopic)\n5. Hysterectomy (open)\n6. Hysterectomy (vaginal)\n7. Colectomy (laparoscopic)\n8. Colectomy (open)\n9. Thyroidectomy\n10. C section\n11. High gastric bypass\n12. Laparoscopy\n13. Prostatectomy\n\nSurgery with potential preoperative pain\n\n1. Cholecystectomy (laparoscopic)\n2. Cholecystectomy (open)\n3. Total knee arthroplasty\n4. Knee arthroscopy\n5. Total hip arthroplasty\n6. Extracorporeal circulation auxiliary to open heart surgery\n7. Spinal surgery\n8. Hip arthrotomy\n\nExclusion Criteria:\n\n* patient not fulfilling at least one of the inclusion criteria mentioned above'}, 'identificationModule': {'nctId': 'NCT01467102', 'acronym': 'PAIN-OUT', 'briefTitle': 'euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT Study', 'organization': {'class': 'OTHER', 'fullName': 'European Society of Anaesthesiology'}, 'officialTitle': 'euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT', 'orgStudyIdInfo': {'id': 'euCPSP PAIN-OUT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '\\> 18 years of age'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Clinique Universitaire de St Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZA, University Hospital Of Antwerp', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '93380', 'city': 'Garches', 'country': 'France', 'facility': 'Hopital Raymond Poincare', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}, {'zip': '07749', 'city': 'Jena', 'country': 'Germany', 'facility': 'University Hospital Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'University Hospital Münster UKM', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'University of Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': 'C1', 'city': 'Cork', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'zip': '71100', 'city': 'Foggia', 'country': 'Italy', 'facility': 'Policlinico "Oo. Riuniti"', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Ii Universita Di Napoli (Policlinico)', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '2004', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'National Centre of Emergency Medicine', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '022328', 'city': 'Bucharest', 'country': 'Romania', 'facility': "Emergency Institute of Cardiovascular Diseases Inst. '' Prof. C. C . Iliescu''", 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '70000', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Central Universitty and Emergency Military Hospital "Dr. Carol Davila"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '3550', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Universitario de San Juan', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Universitätsklinikum', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1005', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Lausanne University Hospital', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '1110', 'city': 'Morges', 'country': 'Switzerland', 'facility': 'Ensemble Hospitalier de la Cote in Morges', 'geoPoint': {'lat': 46.51127, 'lon': 6.49854}}, {'zip': '8063', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Stadtspital Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '03022', 'city': 'Kiev', 'country': 'Ukraine', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '1133', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'City Clinical Hospital', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '10009', 'city': 'Zhytomyr', 'country': 'Ukraine', 'facility': 'Zhitomir Regional Oncological centre', 'geoPoint': {'lat': 50.26235, 'lon': 28.67913}}, {'zip': 'TQ2 7AA', 'city': 'Torquay', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'Torbay Hospital', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Esther Pogatzki-Zahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Münster UKM, Munster'}, {'name': 'Ruth Zaslansky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich Schiller University Jena, Germany'}, {'name': 'Winfried Meissner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich Schiller University Jena, Germany'}, {'name': 'Dominique Fletcher, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hôpital Raymond Poincaré AP-HP,Université Versailles St Quentin,Garches, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Society of Anaesthesiology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Jena', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}