Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-19 @ 3:44 AM
Study NCT ID:
NCT02006966
Status:
COMPLETED
Last Update Posted:
2019-04-01
First Post:
2013-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Intraoperative Systemic Lidocaine Infusion on Chronic Postoperative Pain After Video-assisted Thoracic Surgery (VATS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2013-12-04', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing pain score after operation', 'timeFrame': '2 months after operation', 'description': 'Assessing pain score by Short-form McGill pain questionnaire at 2 months after operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic lidocaine', 'postoperative pain', 'Video-assisted thoracic surgery', 'VATS'], 'conditions': ['Lung Cancer(Primary, Metastatic)', 'Benign Lung Mass Requiring Operation']}, 'descriptionModule': {'briefSummary': "Systemic lidocaine infusion may improve the patients' chronic post surgical pain after video-assisted thoracic surgery"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 20 and 65 years\n* ASA class 1 and 2\n* Patients who are scheduled for video-assisted thoracic surgery\n\nExclusion Criteria:\n\n* Allergy to local anesthetics or contraindication to use of lidocaine\n* Pregnancy\n* Severe cardiovascular disease\n* Renal failure\n* Liver failure\n* Neurologic and psychologic disease\n* Chronic treatment with analgesics or chronic pain patients\n* Previous history of thoracic surgery (open or video-assisted)\n* Patients' refusal"}, 'identificationModule': {'nctId': 'NCT02006966', 'briefTitle': 'The Impact of Intraoperative Systemic Lidocaine Infusion on Chronic Postoperative Pain After Video-assisted Thoracic Surgery (VATS)', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0693'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group L', 'description': 'Intravenous lidocaine infusion group', 'interventionNames': ['Drug: Systemic intravenous lidocaine infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Intravenous normal saline infusion - control group', 'interventionNames': ['Drug: Normal saline infusion']}], 'interventions': [{'name': 'Systemic intravenous lidocaine infusion', 'type': 'DRUG', 'description': 'In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.', 'armGroupLabels': ['Group L']}, {'name': 'Normal saline infusion', 'type': 'DRUG', 'description': 'In group C, the patients receive same volume of normal saline', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}