Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2026-01-20 @ 2:03 PM
Study NCT ID:
NCT01062906
Status:
COMPLETED
Last Update Posted:
2011-01-13
First Post:
2010-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Lidocaine for Laparoscopic Cholecystectomy
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'}, {'id': 'D005283', 'term': 'Fentanyl'}], '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'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-12', 'studyFirstSubmitDate': '2010-02-03', 'studyFirstSubmitQcDate': '2010-02-03', 'lastUpdatePostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fentanyl consumption (measured as fentanyl equivalents -mcg)', 'timeFrame': 'postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery'}], 'secondaryOutcomes': [{'measure': 'Pain, Static and Dynamic', 'timeFrame': 'On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery'}, {'measure': 'Opioids side-effects', 'timeFrame': 'On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['intravenous lidocaine', 'postoperative pain', 'laparoscopic surgery', 'opioids', 'opioids side-effects'], 'conditions': ['Postoperative Pain', 'Opioid Consumption']}, 'referencesModule': {'references': [{'pmid': '19138915', 'type': 'BACKGROUND', 'citation': 'Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.'}]}, 'descriptionModule': {'briefSummary': 'Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the recovery room by 30%.\n\nThe purpose of this study was to determine if an i.v. infusion of lidocaine without intraoperative opioids would reduce the amount of fentanyl to the same extent and opioids-related side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* age \\<18 yr or \\> 85 yr,\n* ASA physical status 3 and greater, history of hepatic failure (Child \\& Pug A-C),\n* renal failure (creatinine outside the normal range) or cardiac failure (NYHA I-IV),\n* Adams-Stoke syndrome,\n* severe degrees of sinoatrial, atrioventricular or intraventricular block,\n* organ transplant,\n* diabetes mellitus type 1 and 2,\n* morbid obesity (BMI \\> 40),\n* chronic use of opioids and beta-blockers,\n* known seizures,\n* severe mental impairment,\n* allergy to local anesthetics and to all the medications used in the study, or\n* inability to understand pain assessment.'}, 'identificationModule': {'nctId': 'NCT01062906', 'briefTitle': 'Intravenous Lidocaine for Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'GEN#08-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'The Lidocaine group will receive lidocaine as bolus at the induction of anesthesia followed by a continuous infusion of lidocaine until the end of surgery', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': '1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)', 'armGroupLabels': ['Lidocaine']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl 3 mcg/Kg as bolus at the induction and a continuous infusion of normal saline (NaCl 0.9%) until the end of surgery (skin closure)', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre, Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Franco Carli, MD, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Healt Centre, Department of Anesthesia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Francesco Carli', 'oldOrganization': 'McGill University Health Centre'}}}}