Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT03479320
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation
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': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-06', 'studyFirstSubmitDate': '2018-03-15', 'studyFirstSubmitQcDate': '2018-03-24', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Numeric Rating Scale(NRS)', 'timeFrame': '24 hours', 'description': 'Pain at rest and with cough or movement using the NRS scale, which ranges from 0 to 10; where 0 refers to no pain and 10 refers to most severe pain'}], 'secondaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': '24 hours', 'description': 'Total morphine or morphine equivalent in milligram'}, {'measure': 'Time to first analgesic request', 'timeFrame': '24 hours', 'description': 'Time to first analgesic (ketorolac) request (time counted after skin closure)'}, {'measure': 'Side effects', 'timeFrame': '24 hours', 'description': 'Number of patients with light headedness, sedation, nausea, vomiting will be documented'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '39376771', 'type': 'DERIVED', 'citation': 'Mahato VK, Dongol A, Acharya P, Yadav AK, Subedi A, Jaisani MR. "Can Perioperative Intravenous Lidocaine Decrease Postoperative Pain After Oral and Maxillofacial Surgeries?": A Randomized Clinical Trial. J Maxillofac Oral Surg. 2024 Oct;23(5):1240-1247. doi: 10.1007/s12663-022-01831-1. Epub 2022 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients 18-60 years of age\n* Patients of ASA (American Society of Anesthesiologists) Class I or Class II (I- healthy with no systemic disease, II- mild systemic disease with no functional limitation) who require oral and maxillofacial surgeries under general anesthesia\n\nExclusion Criteria:\n\n* Refusal to give consent.\n* Hypersensitivity or allergy to the study medication.\n* ASA physical status III or more.\n* Subjects with known severe hepatic or renal dysfunction or cardiac dysrhythmia or atrioventricular block.\n* History of taking opioids or antiarrhythmic drugs within 1 week of surgery.\n* History of drug or alcohol abuse\n* History of psychiatric disorders.\n* Patients requiring emergency surgery.\n* Patients unable to comprehend pain assessment'}, 'identificationModule': {'nctId': 'NCT03479320', 'briefTitle': 'Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation', 'organization': {'class': 'OTHER', 'fullName': 'B.P. Koirala Institute of Health Sciences'}, 'officialTitle': 'Efficacy of Perioperative Intravenous Lidocaine Infusion on Postoperative Analgesia in Patients Undergoing Oral and Maxillofacial Surgeries Under General Anesthesia', 'orgStudyIdInfo': {'id': 'IRC/1078/017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine group', 'description': 'Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'They will receive the same volume of 0.9% of normal saline as calculated for the experimental group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Postoperative analgesic effects will be compared between lidocaine and normal saline group', 'armGroupLabels': ['Lidocaine group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Postoperative anlagesic requirements will be calculated and compared with experimental group', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34464', 'city': 'Dharān', 'country': 'Nepal', 'facility': 'B. P. Koirala Institute of Health Sciences', 'geoPoint': {'lat': 26.81436, 'lon': 87.27972}}], 'overallOfficials': [{'name': 'Vivek Kr Mahato, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'B.P. Koirala Institute of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B.P. Koirala Institute of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post graduate resident in Department of Oral and Maxillofacial Surgery', 'investigatorFullName': 'Dr Vivek Kumar Mahato', 'investigatorAffiliation': 'B.P. Koirala Institute of Health Sciences'}}}}