Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT00982618
Status:
COMPLETED
Last Update Posted:
2011-11-28
First Post:
2009-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D004238', 'term': 'Diverticulitis'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000767', 'term': 'Anesthesia, Epidural'}, {'id': 'D013662', 'term': 'Tea'}], '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': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-24', 'studyFirstSubmitDate': '2009-09-22', 'studyFirstSubmitQcDate': '2009-09-22', 'lastUpdatePostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative functional recovery', 'timeFrame': 'daily during hospitalization, and at 4 and 8 weeks after the surgery'}], 'secondaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': 'daily during hospitalization'}, {'measure': 'opioid consumption', 'timeFrame': 'daily during hospitalization'}, {'measure': 'opioid side effects', 'timeFrame': 'daily during hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colon Cancer', 'Inflammatory Bowel Diseases', 'Diverticulitis']}, 'descriptionModule': {'briefSummary': 'This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early post operative physical activity recovery of patients scheduled for laparoscopic colon surgery.\n\nTwenty patients will receive thoracic epidural analgesia, twenty patients will receive intravenous lidocaine plus patient-controlled analgesia (PCA) and twenty patients will receive only PCA.\n\nHypothesis: patients receiving perioperative intravenous lidocaine, post operative recovery will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.', 'detailedDescription': 'This is a blinded randomised study of patients undergoing major laparoscopic abdominal and pelvic surgery. The first group of patients will receive thoracic epidural analgesia, the second group will receive perioperative intravenous lidocaine, the third group will PCA alone and the last group will receive spinal analgesia. Functional restoration assessed by self-administered quality of Life questionnaires (SF-36, CHAMPS, ICFS) and 2 and 6 min walking test will be assessed in the two groups at 3 and 8 weeks after the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled to undergo laparoscopic colonic resection\n\nExclusion Criteria:\n\n* patients who have trouble to understand, read or communicate either in French or in English\n* dementia\n* patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity\n* patients suffering from severe cardiac or respiratory disease (status ASA IV)\n* patients suffering from metastatic carcinoma\n* patients who have a history of chemoradiation within the six months preceding surgery\n* allergy to lidocaine\n* morbid obesity'}, 'identificationModule': {'nctId': 'NCT00982618', 'briefTitle': 'Functional Restoration After Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'officialTitle': 'Post Operative Functional Restoration in Patients Undergoing Major Abdominal and Pelvic Laparoscopic Surgery: Effect of Perioperative Intravenous Lidocaine', 'orgStudyIdInfo': {'id': 'GEN-06-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIDOCAINE group', 'description': 'LIDOCAINE group : Beside general anesthesia, patients will receive intravenous lidocaine bolus 1.5 mg/kg just prior induction and an infusion of lidocaine 2mg/kg/h will be started and maintained during the whole surgical procedure. Entering the recovery room, this infusion will be decreased at the rate of 1mg/kg/hour for the 48 first hours', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Epidural Group', 'description': 'Epidural Group: Beside general anesthesia, patient will receive epidural freezing medication for 48 hours.', 'interventionNames': ['Procedure: Epidural Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCA group', 'description': 'Beside general anesthesia, the patients will receive neither lidocaine nor epidural catheter. The patients will receive the same analgesia protocol consisting of PCA morphine for a total duration of 48 hours.', 'interventionNames': ['Drug: PCA Morphine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Intravenous local anesthetic infusion'], 'description': '1% Lidocaine 1mg/kg/hr IV drip x 48hr', 'armGroupLabels': ['LIDOCAINE group']}, {'name': 'Epidural Block', 'type': 'PROCEDURE', 'otherNames': ['Thoracic epidural analgesia'], 'description': '0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr', 'armGroupLabels': ['Epidural Group']}, {'name': 'PCA Morphine', 'type': 'DRUG', 'otherNames': ['Patient Control Analgesia Morphine.'], 'description': 'PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.', 'armGroupLabels': ['PCA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Franco Carli, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Healt Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Gabriele Baldini, Assistant Professor', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}