Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT01180660
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2010-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'g-jr@northwestern.edu', 'phone': '312-472-3573', 'title': 'Gildasio De Oliveira MD', 'organization': 'Northwestern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We did not evaluate if the opioid sparing properties of systemic lidocaine resulted in a lower incidence of adverse respiratory events (hypoxemia/hypoventilation). We were underpowered to detect significant differences in certain parts of the qor-40.'}}, 'adverseEventsModule': {'timeFrame': '24 hours after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine', 'description': 'Lidocaine infusion\n\nLidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period', 'otherNumAtRisk': 24, 'otherNumAffected': 5, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo Normal Saline Infusion\n\nNormal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period', 'otherNumAtRisk': 26, 'otherNumAffected': 14, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'notes': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Nausea'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Recovery 40 on the Day After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': 'Lidocaine infusion\n\nLidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Normal Saline Infusion\n\nNormal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period'}], 'classes': [{'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000', 'lowerLimit': '151', 'upperLimit': '170'}, {'value': '146', 'groupId': 'OG001', 'lowerLimit': '130', 'upperLimit': '169'}]}]}], 'analyses': [{'pValue': '.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19', 'ciLowerLimit': '3', 'ciUpperLimit': '27', 'groupDescription': 'A sample size of 22 subjects per group was estimated to achieve 90% power to detect a 16 point difference in the aggregated Qor-40 score for the two study groups to be compared assuming an overall standard deviation of 16 points similar to what was observed in a previous investigation.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.\n\nThe minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.', 'unitOfMeasure': 'units on scale 40 (low) - 200 (high)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '24 Hour Total Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine', 'description': 'Lidocaine infusion\n\nLidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo Normal Saline Infusion\n\nNormal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '46'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours post surgery', 'description': '24 hour total opioid consumption using IV morphine equivalents', 'unitOfMeasure': 'miligrams', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine', 'description': 'Lidocaine infusion\n\nLidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo Normal Saline Infusion\n\nNormal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Changed to open surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '51 subjects were randomized and 50 completed the study. Subjects were enrolled consecutively from August 2010 through October 2012.', 'preAssignmentDetails': '60 subjects were assessed for eligibility and 9 were excluded because they did not meet inclusion criteria n=3 or the subject refused n=6.\n\n51 subjects were randomized to the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine', 'description': 'Lidocaine infusion\n\nLidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo Normal Saline Infusion\n\nNormal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period'}, {'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': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '54'}, {'value': '48', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '53'}, {'value': '47', 'groupId': 'BG002', 'lowerLimit': '43', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Unit of measure (kg/m2)', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-15', 'studyFirstSubmitDate': '2010-07-19', 'resultsFirstSubmitDate': '2014-04-08', 'studyFirstSubmitQcDate': '2010-08-11', 'lastUpdatePostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-15', 'studyFirstPostDateStruct': {'date': '2010-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery 40 on the Day After Surgery', 'timeFrame': '24 hours', 'description': 'Quality of Recovery 40 on the Day After Surgery. The survey is a quality of recovery tool and a score of 40 is low and 200 is high.\n\nThe minimum score is 40 which is minimum recovery score and them maximum score is 200 which is considered better recovery.'}], 'secondaryOutcomes': [{'measure': '24 Hour Total Opioid Consumption', 'timeFrame': '24 hours post surgery', 'description': '24 hour total opioid consumption using IV morphine equivalents'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastric Surgery', 'Pain', 'Recovery', 'Laparoscopic Surgery'], 'conditions': ['Pain', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '11179243', 'type': 'BACKGROUND', 'citation': 'Mun EC, Blackburn GL, Matthews JB. Current status of medical and surgical therapy for obesity. Gastroenterology. 2001 Feb;120(3):669-81. doi: 10.1053/gast.2001.22430.'}, {'pmid': '6691724', 'type': 'BACKGROUND', 'citation': 'Peiser J, Lavie P, Ovnat A, Charuzi I. Sleep apnea syndrome in the morbidly obese as an indication for weight reduction surgery. Ann Surg. 1984 Jan;199(1):112-5. doi: 10.1097/00000658-198401000-00020.'}, {'pmid': '9717428', 'type': 'BACKGROUND', 'citation': 'Kyzer S, Charuzi I. Obstructive sleep apnea in the obese. World J Surg. 1998 Sep;22(9):998-1001. doi: 10.1007/s002689900506.'}, {'pmid': '8652329', 'type': 'BACKGROUND', 'citation': 'Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available.'}, {'pmid': '3354874', 'type': 'BACKGROUND', 'citation': 'Alexander CM, Gross JB. Sedative doses of midazolam depress hypoxic ventilatory responses in humans. Anesth Analg. 1988 Apr;67(4):377-82.'}, {'pmid': '10718794', 'type': 'BACKGROUND', 'citation': 'Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. doi: 10.1046/j.1365-2168.2000.01374.x.'}, {'pmid': '10910857', 'type': 'BACKGROUND', 'citation': 'Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. doi: 10.1097/00000539-200008000-00032.'}, {'pmid': '11703235', 'type': 'BACKGROUND', 'citation': 'Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. doi: 10.1046/j.1365-2044.2001.02215.x.'}, {'pmid': '9861124', 'type': 'BACKGROUND', 'citation': 'Moiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. doi: 10.1093/bja/81.3.377.'}]}, 'descriptionModule': {'briefSummary': 'Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery.\n\nThis study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I, II,III;\n* BMI \\> 35 kg/m2,\n* Age between 18-70,\n* Fluent in English,\n* Patients undergoing laparoscopic gastric bypass,\n* EKG within 3 months.\n\nExclusion Criteria:\n\n* History of allergy to local anesthetics,\n* History of chronic opioid use,\n* Pregnant patients,\n* History of EKG abnormalities.\n\nDropout: Conversion to open, patient or surgeon request.'}, 'identificationModule': {'nctId': 'NCT01180660', 'briefTitle': 'IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'The Effect of Systemic Intraoperative Lidocaine on Postoperative Pain and Quality of Recovery on Morbid Obese Patients Undergoing Laparoscopic Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': 'STU00032300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Lidocaine infusion', 'interventionNames': ['Drug: Lidocaine Infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Normal Saline Infusion', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Lidocaine Infusion', 'type': 'DRUG', 'description': '1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period', 'armGroupLabels': ['Lidocaine']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['Placebo infusion'], 'description': 'Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Gildasio De Oliveira, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gildasio De Oliveira, M.D. Principal Investigator', 'investigatorFullName': 'Gildasio De Oliveira', 'investigatorAffiliation': 'Northwestern University'}}}}