Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-27 @ 4:35 AM
Study NCT ID:
NCT02599233
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2015-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2015-11-05', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The pain trajectory for the first 7 post-operative days.', 'timeFrame': 'Day 7 post-surgery', 'description': 'The pain trajectory is the vector of 7 verbal numerical pain estimates (from 0 to 10) taken over 7 days (days 1 (or -1), 2, 3, 4, 5, 6 \\& 7).\n\nDay 0 is the day of surgery.'}], 'secondaryOutcomes': [{'measure': 'The DN4 questionnaire', 'timeFrame': 'month 3'}, {'measure': 'Since the surgery, do you have persistent pain? yes/no', 'timeFrame': 'month 3'}, {'measure': 'Is it the same pain before the surgery? yes/no', 'timeFrame': 'month 3'}, {'measure': 'Verbal numberical scale for pain (ranging from 0 to 10)', 'timeFrame': 'month 3'}, {'measure': 'Have you had complications from your surgery? yes/no', 'timeFrame': 'month 3'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'day -1 or day +1'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'day -1 or day +1'}, {'measure': 'Cumulative consumption of antalgic drugs', 'timeFrame': 'day -1 or day +1'}, {'measure': 'Cumulative consumption of antalgic drugs', 'timeFrame': 'day 2'}, {'measure': 'Cumulative consumption of antalgic drugs', 'timeFrame': 'day 3'}, {'measure': 'Cumulative consumption of antalgic drugs', 'timeFrame': 'day 4'}, {'measure': 'Cumulative consumption of antalgic drugs', 'timeFrame': 'day 5'}, {'measure': 'Cumulative consumption of antalgic drugs', 'timeFrame': 'day 6'}, {'measure': 'Cumulative consumption of antalgic drugs', 'timeFrame': 'day 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain trajectory'], 'conditions': ['Surgical Procedures, Operative', 'Pain', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '33359373', 'type': 'RESULT', 'citation': "L'Hermite J, Page MG, Chevallier T, Occean B, Viel E, Bredeau O, Lefrant JY, Cuvillon P. Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study). Anaesth Crit Care Pain Med. 2021 Feb;40(1):100793. doi: 10.1016/j.accpm.2020.100793. Epub 2020 Dec 23."}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.', 'detailedDescription': 'The secondary objectives of this study are:\n\nA. To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.\n\nB. To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.\n\nC. To study the potential links between pain trajectories and the presence or absence of PSCP.\n\nD. To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program for a predefined six month period and for a predefined list of surgeries. The latter list of surgical acts was established according to the Medicalization of Information Systems Progam (PMSI) database. Patients are recruited either the day before or the day after surgery, in their respective departments.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is available for 3 months of follow-up\n* The patient has undergone a planned surgical procedure in one of the participating departments\n* The patient is willing and able to respond to the study questionnaires (HADS, PCS, EN, DN4)\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* It is impossible to correctly inform the patient\n* Patient admitted to the ICU and still intubated at day 1'}, 'identificationModule': {'nctId': 'NCT02599233', 'acronym': 'PATCH', 'briefTitle': 'Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital', 'orgStudyIdInfo': {'id': 'LOCAL/2015/JLH-01'}, 'secondaryIdInfos': [{'id': '2015-A00868-41', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'The study population', 'description': 'The study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program for a predefined six month period and for a predefined list of surgeries. The latter list of surgical acts was established according to the Medicalization of Information Systems Progam (PMSI) database. Patients are recruited either the day before or the day after surgery, in their respective departments.\n\nInterventions:\n\n* In hospital pain evaluation\n* In hospital questionnaires\n* Telephone conctact at 3 months', 'interventionNames': ['Other: Telephone conctact at 3 months', 'Other: In hospital pain evaluation', 'Other: In hospital questionnaires']}], 'interventions': [{'name': 'Telephone conctact at 3 months', 'type': 'OTHER', 'description': 'Patients will be contacted at 3 months post-surgery for pain questionnaires.', 'armGroupLabels': ['The study population']}, {'name': 'In hospital pain evaluation', 'type': 'OTHER', 'description': 'Patients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 \\& 7.', 'armGroupLabels': ['The study population']}, {'name': 'In hospital questionnaires', 'type': 'OTHER', 'description': 'Patients are required to fill out the HADS and PCS questionnaires between on day -1 or +1.', 'armGroupLabels': ['The study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': "Joël L'Hermite, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}