Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-29 @ 8:20 AM
Study NCT ID:
NCT00913003
Status:
TERMINATED
Last Update Posted:
2015-02-04
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
Sponsor:
Organization:
Raw JSON
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'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was terminated early because the PI left the institution.'}}, 'adverseEventsModule': {'timeFrame': '14 days', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Group B using saline as a placebo.\n\nPlacebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lidocaine', 'description': 'Group A lidocaine infusion and bolus.\n\nLidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)', 'otherNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'First degree heart block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Post Operative Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Group B using saline as a placebo.\n\nPlacebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug'}, {'id': 'OG001', 'title': 'Lidocaine', 'description': 'Group A lidocaine infusion and bolus.\n\nLidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Immediate post operative to 48 hours', 'description': 'Nausea at any time during the post operative period for 48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Post Operative Ileus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Group B using saline as a placebo.\n\nPlacebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug'}, {'id': 'OG001', 'title': 'Lidocaine', 'description': 'Group A lidocaine infusion and bolus.\n\nLidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '24 Hour Hydromorphone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Group B using saline as a placebo.\n\nPlacebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug'}, {'id': 'OG001', 'title': 'Lidocaine', 'description': 'Group A lidocaine infusion and bolus.\n\nLidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hour', 'description': 'Total IV hydromorphone administered during surgery to 24 hours post surgery', 'unitOfMeasure': 'miligrams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Group B using saline as a placebo.\n\nPlacebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug'}, {'id': 'FG001', 'title': 'Lidocaine', 'description': 'Group A lidocaine infusion and bolus.\n\nLidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Group B using saline as a placebo.\n\nPlacebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug'}, {'id': 'BG001', 'title': 'Lidocaine', 'description': 'Group A lidocaine infusion and bolus.\n\nLidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '9.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'PI terminated employment with the University', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2009-06-02', 'resultsFirstSubmitDate': '2015-01-21', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-02', 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24 Hour Hydromorphone', 'timeFrame': '24 hour', 'description': 'Total IV hydromorphone administered during surgery to 24 hours post surgery'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Experiencing Post Operative Nausea', 'timeFrame': 'Immediate post operative to 48 hours', 'description': 'Nausea at any time during the post operative period for 48 hours'}, {'measure': 'Number of Participants Experiencing Post Operative Ileus', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lidocaine', 'Mastectomy', 'Pain'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '9459225', 'type': 'BACKGROUND', 'citation': 'Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.'}, {'pmid': '15763418', 'type': 'BACKGROUND', 'citation': 'Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005 Mar;23(1):185-202. doi: 10.1016/j.atc.2004.11.010.'}, {'pmid': '17197840', 'type': 'BACKGROUND', 'citation': 'Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.'}, {'pmid': '15041597', 'type': 'BACKGROUND', 'citation': 'Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.'}, {'pmid': '15655557', 'type': 'BACKGROUND', 'citation': 'Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.'}, {'pmid': '17592992', 'type': 'BACKGROUND', 'citation': 'McCleane G. Intravenous lidocaine: an outdated or underutilized treatment for pain? J Palliat Med. 2007 Jun;10(3):798-805. doi: 10.1089/jpm.2006.0209.'}, {'pmid': '18547294', 'type': 'BACKGROUND', 'citation': 'Owczuk R, Wujtewicz MA, Sawicka W, Piankowski A, Polak-Krzeminska A, Morzuch E, Wujtewicz M. The effect of intravenous lidocaine on QT changes during tracheal intubation. Anaesthesia. 2008 Sep;63(9):924-31. doi: 10.1111/j.1365-2044.2008.05525.x. Epub 2008 Jun 10.'}, {'pmid': '18682714', 'type': 'BACKGROUND', 'citation': 'Violet JA, Dearling JL, Green AJ, Begent RH, Pedley RB. Fractionated 131I anti-CEA radioimmunotherapy: effects on xenograft tumour growth and haematological toxicity in mice. Br J Cancer. 2008 Aug 19;99(4):632-8. doi: 10.1038/sj.bjc.6604511.'}, {'pmid': '17457830', 'type': 'BACKGROUND', 'citation': 'Cheville AL, Tchou J. Barriers to rehabilitation following surgery for primary breast cancer. J Surg Oncol. 2007 Apr 1;95(5):409-18. doi: 10.1002/jso.20782.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome.\n\nThis study will have 2 groups. Participants will be randomized into one of each group. The first group will be administered the drug lidocaine prior to surgery and the second group Group B will be administered saline (salt water). This is a blinded study which means the participant will not know which group they have been assigned. The subjects participation will last 12 months (surveys post operatively).', 'detailedDescription': 'Patients will be recruited up to 21 days prior to the day of surgery. The consent form will be reviewed with the patient, and the patient will be allowed to take a copy home. If the patient does not have an EKG within the past 6 weeks in her medical record, an EKG will be obtained at the time of recruitment. At the time of recruitment, the patient will be randomized using a computer-generated code. Group A will receive lidocaine during surgery, and Group B will receive saline (placebo) during surgery.The study drug will be prepared by the investigator(s). The anesthesiologist and research nurse will be blinded. If necessary in the event of an emergency, these individuals may be unblinded.\n\nGroup A (Lidocaine):\n\nInduction: 1.5 mg/kg IV (IBW) bolus, administered prior to Propofol. The maximum loading dose administered will not exceed 150 mg IV Infusion: 33.3 mcg/kg/min IV (IBW), initiated before surgical incision.Discontinue infusion 1 hour after skin closure complete.No other local anesthetics administered intra-operatively\n\nGroup B (Saline):\n\nInduction: IV bolus, administered prior to Propofol Infusion: Initiate before surgical incision (rate calculated as if for lidocaine infusion). Discontinue infusion 1 hour after skin closure complete No local anesthetics administered intra-operatively. Baseline thermal quantitative sensory testing (QST) scores will be obtained pre-operatively using TSA-II Neuro Sensory Analyzer (Medoc Advanced Medical Systems, Durham, NC).\n\nBaseline Modified Quality of Recovery (MQoR-40) Survey will be obtained on the morning of surgery.\n\nPreoperative anxiety, depression, and pain characterization will be measured within 24 hours of the time of surgery using a validated questionnaire (Hospital Anxiety and Depression Scale). If the questionnaire responses indicate the patient is experiencing depressive symptoms, the patient will be notified of the results and instructed to follow up with her primary care physician.\n\nIntraoperatively, patients will receive a standardized anesthetic (management protocol attached).\n\nTwo blood samples for lidocaine levels will be obtained on subjects. The first lidocaine blood sample will be collected after the lidocaine/placebo bolus in the operating room. The second lidocaine blood sample will be obtained when the lidocaine/placebo infusion has been discontinued (one hour after skin closure). A total of 5 mLs of blood will be obtained.\n\nPatients will be examined daily by a research nurse while admitted to the hospital. Daily pain scores will be noted, as will complications related to the perioperative period. If the subject is discharged within 24 hours the research nurse will call by phone to ask the subject about pain 0-10 and type and amount of pain relievers used since discharge.MQoR-40 will be administered on the day of discharge. It will be repeated at 6 weeks, 6 months, and 12 months after surgery. Patients will complete the Mastectomy Patient Follow-Up, Modified LANNS Pain Scale, and McGill Pain questionnaires at 6 months and 12 months after surgery for detection of Post-Mastectomy Pain Syndrome (PMPS).\n\nThe definition of PMPS will be: The presence of a dull, burning,and aching sensation in the anterior chest, arm, and axilla exacerbated by movement of the shoulder girdle.\n\nAppendix 1-Anesthetic Management Protocol Appendix 2-HADS Appendix 3-MQoR-40 Appendix 4-Modified LANNS and McGill Appendix 5-Follow-Up Questionnaire'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-65 years\n* Gender: Female\n* ASA Physical Status I-III\n* Non-pregnant\n* Surgery: Unilateral total or segmental mastectomy\n* Language: English speaking\n* Consent: Obtained\n\nExclusion Criteria:\n\n* Age: Under 18 or over 65 years\n* ASA Physical Status \\>III\n* Pregnancy\n* Language: Non-English speaking\n* Allergy to Lidocaine or amide local anesthetics\n* Contraindication to succinylcholine\n* History and/or EKG evidence of conduction defect\n* Renal failure (Creatinine \\>1.7 mg/dL)\n* Patient expected to remain intubated after procedure\n* Chronic home opioid or steroid use\n* Opioid use within one week prior to procedure\n* Drug or alcohol abuse\n* Inability to use PCA'}, 'identificationModule': {'nctId': 'NCT00913003', 'briefTitle': 'Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery', 'orgStudyIdInfo': {'id': 'STU0008753'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group B using saline as a placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine', 'description': 'Group A lidocaine infusion and bolus.', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Group A'], 'description': 'Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)', 'armGroupLabels': ['Lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Group B'], 'description': 'Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christian Altman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Altman', 'investigatorAffiliation': 'Northwestern University'}}}}