Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-11 @ 12:40 AM
Study NCT ID:
NCT01507493
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2012-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'znpain@sina.com', 'phone': '13037154560', 'title': 'Xianwei Zhang', 'organization': 'Huazhong University of Science&Technology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.', 'otherNumAtRisk': 178, 'otherNumAffected': 0, 'seriousNumAtRisk': 178, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Opioid Consumption Dose 48h After Operation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'id': 'OG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.4', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '50.4', 'spread': '20.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after the operation', 'unitOfMeasure': 'microgramme', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Visual Analog Scale 48h After Operation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'id': 'OG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after the operation', 'description': 'The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preoperative Pressure Pain Threshold (PPT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'id': 'OG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours before the operation', 'description': 'The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "pain" when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.', 'unitOfMeasure': 'kg/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PCA Press Frequency 48h After Operation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'id': 'OG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '19.9', 'spread': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after the operation', 'unitOfMeasure': 'presses per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preoperative Pressure Pain Tolerance (PTO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'id': 'OG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours before the operation', 'description': 'The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "ok" when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.', 'unitOfMeasure': 'kg/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'id': 'FG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mutant Alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'id': 'BG001', 'title': 'Wild-type Alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.9', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '55.2', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Heparin anti-coagulated blood (2 ml) was collected from the central venous during the operation and all blood samples were stored at -80℃. Genomic DNA was extracted from the blood samples using a guanidinium isothiocyanate method.'}, 'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-31', 'studyFirstSubmitDate': '2012-01-02', 'resultsFirstSubmitDate': '2013-05-30', 'studyFirstSubmitQcDate': '2012-01-06', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-31', 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Consumption Dose 48h After Operation.', 'timeFrame': '48 hours after the operation'}, {'measure': 'PCA Press Frequency 48h After Operation.', 'timeFrame': '48 hours after the operation'}], 'secondaryOutcomes': [{'measure': 'The Visual Analog Scale 48h After Operation.', 'timeFrame': '48 hours after the operation', 'description': 'The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain'}, {'measure': 'Preoperative Pressure Pain Threshold (PPT)', 'timeFrame': '12 hours before the operation', 'description': 'The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "pain" when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.'}, {'measure': 'Preoperative Pressure Pain Tolerance (PTO)', 'timeFrame': '12 hours before the operation', 'description': 'The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "ok" when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gene polymorphism', 'SCN9A', 'pain perception', 'postoperative pain'], 'conditions': ['Pain', 'Surgery']}, 'descriptionModule': {'briefSummary': 'This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press frequency and drug consumption were recorded.', 'detailedDescription': 'Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '800 Chinese patients receiving elective upper abdominal surgery under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 20-70 years\n* Receiving elective upper abdominal surgery\n* Anesthesiologists (ASA) physical status I or II\n* Received PCA administration\n* Agreed to participate the research\n\nExclusion Criteria:\n\n* History of chronic pain\n* Psychiatric diseases\n* Diabetes mellitus\n* Severe cardiovascular diseases\n* Kidney or liver diseases\n* Alcohol or drug abuse\n* Heavy smoker\n* Pregnancy or at lactation period\n* Refused PCA administration\n* Disagree to participate to the research'}, 'identificationModule': {'nctId': 'NCT01507493', 'briefTitle': 'The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population', 'orgStudyIdInfo': {'id': 'SCN9A'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mutant alleles', 'description': 'grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.'}, {'label': 'wild-type alleles', 'description': 'grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Zhang Xianwei, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xianwei Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xianwei Zhang', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}