Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2026-03-14 @ 11:37 AM
Study NCT ID:
NCT01767168
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2013-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'venous blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-29', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2016-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of pain at the site of surgery', 'timeFrame': '4 months postop', 'description': 'clinically important pain defined as either necessitating analgesic treatment or having an intensity of more than 3/10 at rest or 5/10 on movement, at 4 months after surgery'}], 'secondaryOutcomes': [{'measure': 'acute pain', 'timeFrame': '24h', 'description': 'maximum pain \\>3/10'}, {'measure': 'subacute pain', 'timeFrame': '1 week', 'description': 'average pain, maximum pain \\>2'}, {'measure': 'prevalence of pain necessitating analgesics at the site of surgery', 'timeFrame': '4 months'}, {'measure': 'prevalence of pain at the site of surgery', 'timeFrame': '8 months'}, {'measure': 'prevalence of pain at the site of surgery', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women scheduled for any type of breast cancer surgery in a university hospital breast cancer center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>=18 years\n* American Society of Anesthesiology functional status I-III\n* able to read and understand the information sheet and give informed consent\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT01767168', 'acronym': 'PREDO', 'briefTitle': 'Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test', 'orgStudyIdInfo': {'id': 'CER 10-218'}, 'secondaryIdInfos': [{'id': 'matped 10-054', 'type': 'OTHER', 'domain': 'local ethics committee'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'comprehensive preoperative testing for risk factors of persistent postoperative pain', 'type': 'OTHER', 'description': 'nociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Benno Rehberg-Klug, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Anesthesiology, HUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'médecin adjoint agrégé', 'investigatorFullName': 'Benno Rehberg-Klug', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}