Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04228705
Status:
UNKNOWN
Last Update Posted:
2020-01-14
First Post:
2020-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2020-01-12', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain trajectories after surgery', 'timeFrame': 'within 6 months', 'description': 'The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with pain severity domain of the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R)'}, {'measure': 'Pain trajectories after surgery', 'timeFrame': 'within 6 months', 'description': 'The pain trajectory is the vector of mean pain severity domain score (from 0 to 10) measured with Brief Pain Inventory -Short Form (BPI-SF) within 6 months'}], 'secondaryOutcomes': [{'measure': 'Outcome of 6-mins-walking test', 'timeFrame': '1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation', 'description': 'Walking distance of 6 minutes'}, {'measure': 'Postoperative duration of stay in hospital', 'timeFrame': '30 days postoperation', 'description': 'The duration when patients stay in hospital after surgery.'}, {'measure': 'Number of readmission within 30 days after surgery', 'timeFrame': 'Up to 30 days postoperation', 'description': 'Readmission indicates unplanned readmission after hospital discharge.'}, {'measure': 'Complications within 30 days after surgery', 'timeFrame': 'Up to 30 days postoperation', 'description': 'Complications within 30 days after surgery will be classified using Clavien-Dindo Classification of Surgical Complications, ranging from Grade I(Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions) to Grade V(death of a patient).'}, {'measure': 'The trajectories of health related quality of life(HRQoL)', 'timeFrame': '1, 3, 7, 14, 21, 30, 60, 90, 120, 150 and180 days postoperation', 'description': "The trajectory of HRQoL is the vector of Utility values measured with EuroQol five-dimensional questionnaire(EQ-5D)taken over 6 months(days 1, 3, 7,14, 21, 30, 60, 90, 120, 150,180; Day 0 is the day of surgery). The EQ-5D measures health on five domains (mobility, self-care, usual activities, pain discomfort, and anxiety-depression), and the scores will be combined using Chinese general population weights to generate a single utility or index score. Utility values for the EQ-5D range from 1.00 to -0.391, where a score of 0 and 1 are regarded as equivalent to death and 'perfect health', respectively, and a score \\< 0 is considered as health state that is 'worse than death'."}, {'measure': 'Ambulation time', 'timeFrame': 'Up to 30 days postoperation', 'description': 'The first time when patients can get off of bed and walk after surgery'}, {'measure': 'Oral feeding time', 'timeFrame': 'Up to 30 days postoperation', 'description': 'The first time when patients begin oral feeding after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Pain Assessment', 'Elderly', 'Model']}, 'descriptionModule': {'briefSummary': 'This study will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.', 'detailedDescription': 'This study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. Analyzing these collected data to find the high-risk factors of postoperative pain in elderly patients and to establish an early-warning model of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years or older undergoing general or regional anesthesia of any procedures, mainly include: breast surgery, thoracic surgery, abdominal surgery, total knee or hip replacement surgery and spine surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Undergoing general or regional anesthesia\n* Hospitalized for at least 24 hours after surgery\n* Able to give informed consent\n* Able to read and write\n\nExclusion Criteria:\n\n* Existing diagnoses of psychiatric or neurologic pathology\n* A history of substance abuse\n* Admitted to ICU after surgery\n* Patients with advanced tumors who have received preoperative chemotherapy or who are expected to receive postoperative chemotherapy.'}, 'identificationModule': {'nctId': 'NCT04228705', 'briefTitle': 'Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Study on Comprehensive Strategy of Perioperative Pain Prevention and Treatment in Elderly Patients -- Establishment and Validation of Early-warning Model of Perioperative Pain for the Elders', 'orgStudyIdInfo': {'id': '2019PHB258-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The elders', 'description': 'Patients aged over 59 years old'}, {'label': 'The young adults', 'description': 'Patients aged from 18 to 59 years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Feng, MD', 'role': 'CONTACT', 'email': 'yifeng65@sina.com', 'phone': '08601088325590'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Feng Yi, MD, PhD', 'role': 'CONTACT', 'email': 'yifeng65@sina.com', 'phone': '86-010-88325590'}], 'overallOfficials': [{'name': 'Feng Yi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of department of anesthesiology and pain management', 'investigatorFullName': 'Yi Feng, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}