Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT03916120
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2019-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2019-04-08', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative analgesic failure', 'timeFrame': '8 a.m. at the first day after surgery.', 'description': 'Once patient experience at least one of the following situations:\n\n1. Bad patients sleep quality\n2. Require extra analgesic drug\n3. Low satisfaction with pain control\n4. Bolus times \\> 1 per hour'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Thoracic Surgery, Video-Assisted', 'Polymorphism, Single Nucleotide']}, 'referencesModule': {'references': [{'pmid': '32024468', 'type': 'DERIVED', 'citation': 'Xing X, Bai Y, Sun K, Yan M. Single nucleotide polymorphisms associated with postoperative inadequate analgesia after single-port VATS in Chinese population. BMC Anesthesiol. 2020 Feb 5;20(1):38. doi: 10.1186/s12871-020-0949-6.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Different patients experience different pain intensity. This suggests that there may be genetic variants that make some patients susceptible to analgesic failure. Using blood samples from patients, the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in analgesic failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving single-port video-assisted thoracoscopic surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≤ 70 and Age ≥18\n* Selective operation lung section with video-assisted thoracic surgery (VATS)\n* III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I\n* Patients informed and agreed to join the study\n\nExclusion Criteria:\n\n* Abnormal function of liver and kidney\n* Allergic- dependence history of alcohol, opioids and Local anesthetics\n* No noncompliance\n* Mental disease history，language communication disorder，cicatricial diathesis\n* Underweight or overweight（BMI\\<18 or \\>30)\n* Patients not suitable for clinical subjects for other reasons\n* Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24hours before the operation.\n* History of previous abnormal anaesthesia\n* Women during pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03916120', 'briefTitle': 'Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure After Single-port Video-Assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': '2018-067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postoperative Analgesic Failure', 'interventionNames': ['Genetic: Genetic analysis']}, {'label': 'Postoperative Analgesic Success', 'interventionNames': ['Genetic: Genetic analysis']}], 'interventions': [{'name': 'Genetic analysis', 'type': 'GENETIC', 'description': 'Collect 2ml intravenous blood from patients after anaesthesia.', 'armGroupLabels': ['Postoperative Analgesic Failure', 'Postoperative Analgesic Success']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The second affiliated hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Min Min, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}