Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-02-27 @ 6:39 PM
Study NCT ID:
NCT00613834
Status:
COMPLETED
Last Update Posted:
2019-12-19
First Post:
2008-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intrauterine Lidocaine Infusion for Essure Sterilization Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Michelle.Isley@osumc.edu', 'phone': '614-293-4203', 'title': 'Dr. Michelle Isley', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Difference in reported abortions between the two groups. Data not included on three subjects in saline group because the subjects could not tolerate the procedure.'}}, 'adverseEventsModule': {'timeFrame': 'From enrollment to 30 minutes post-procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine Group', 'description': 'Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Saline Group', 'description': 'Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Patient-perceived Pain Between Baseline and Cannulization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Group', 'description': 'Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization'}, {'id': 'OG001', 'title': 'Saline Group', 'description': 'Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '73'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '-18.5', 'upperLimit': '82'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately after speculum insertion and immediately after cannulization', 'description': 'Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannulization: a negative change in VAS score between baseline and cannulization indicates less pain during cannulization and a positive change in VAS score indicates more pain during cannulization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Perceived Pain 30 Minutes Post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Group', 'description': 'Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization\n\nLidocaine: 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization\n\nSterile Saline: 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '76'}, {'value': '32.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '97'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 minutes post-procedure', 'description': 'Patients rated their pain 30 minutes after speculum removal using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction With the Essure Tubal Sterilization Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Group', 'description': 'Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization'}, {'id': 'OG001', 'title': 'Saline Group', 'description': 'Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '100'}, {'value': '93.5', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 minutes post-procedure', 'description': 'Patients reported their overall satisfaction with the Essure tubal sterilization procedure using a Visual Analog scale (VAS), range 0-100. A score of 0 indicates lowest possible satisfaction and a score of 100 indicates highest possible satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Group', 'description': 'Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization'}, {'id': 'FG001', 'title': 'Saline Group', 'description': 'Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Group', 'description': 'Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization'}, {'id': 'BG001', 'title': 'Saline Group', 'description': 'Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization'}, {'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': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '33.8', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', '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': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-14', 'studyFirstSubmitDate': '2008-01-31', 'resultsFirstSubmitDate': '2012-04-09', 'studyFirstSubmitQcDate': '2008-02-12', 'lastUpdatePostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-14', 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Patient-perceived Pain Between Baseline and Cannulization', 'timeFrame': 'Immediately after speculum insertion and immediately after cannulization', 'description': 'Patients rated their pain following speculum insertion (used as baseline) and after insertion of a cannula into both fallopian tubes. Reported pain during cannulization of the right and left fallopian tubes were averaged to obtain the measurement of pain at cannulization. Pain was reported using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable. Baseline pain levels were subtracted from average pain during cannulization: a negative change in VAS score between baseline and cannulization indicates less pain during cannulization and a positive change in VAS score indicates more pain during cannulization.'}], 'secondaryOutcomes': [{'measure': 'Patient Perceived Pain 30 Minutes Post-procedure', 'timeFrame': '30 minutes post-procedure', 'description': 'Patients rated their pain 30 minutes after speculum removal using a Visual Analog Scale (VAS, range 0-100), where a score of 0 indicates no pain and a score of 100 indicates the worst pain imaginable.'}, {'measure': 'Patient Satisfaction With the Essure Tubal Sterilization Procedure', 'timeFrame': '30 minutes post-procedure', 'description': 'Patients reported their overall satisfaction with the Essure tubal sterilization procedure using a Visual Analog scale (VAS), range 0-100. A score of 0 indicates lowest possible satisfaction and a score of 100 indicates highest possible satisfaction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Essure sterilization', 'pain management', 'intrauterine lidocaine infusion'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '22067774', 'type': 'DERIVED', 'citation': 'Isley MM, Jensen JT, Nichols MD, Lehman A, Bednarek P, Edelman A. Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization: a randomized controlled trial. Contraception. 2012 Mar;85(3):275-81. doi: 10.1016/j.contraception.2011.06.015. Epub 2011 Aug 17.'}], 'seeAlsoLinks': [{'url': 'http://www.ohsuwomenshealth.com/research/index.html', 'label': "(Women's Health Research Unit website)"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.', 'detailedDescription': 'We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal sterilization.\n\nWe plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Age 18 or older\n* Good general health, based on the opinion of the investigator\n* Voluntarily requesting permanent sterilization\n* Negative pregnancy test\n* Agree to premedication with ibuprofen and ativan\n* English speaking, or other language if an interpreter is available to be present at all points of the study procedure.\n* Willing and able to sign an informed consent\n* Willing to comply with the terms of the study\n\nExclusion Criteria:\n\n* Significant physical or mental health condition, based on the opinion of the investigator.\n* Positive pregnancy test\n* Request for IV/IM sedation prior to the start of the procedure\n* Refusal of ibuprofen, ativan, or paracervical block\n* Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate\n* History of toxic reaction to local anesthetics\n* Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)\n* Weight less than 100 pounds. \\[Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)\\].\n* Current participation in another research study which would interfere with the conduct of this study.'}, 'identificationModule': {'nctId': 'NCT00613834', 'briefTitle': 'Intrauterine Lidocaine Infusion for Essure Sterilization Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Intrauterine Lidocaine Infusion for Pain Management During Outpatient Essure Transcervical Tubal Sterilization Procedures', 'orgStudyIdInfo': {'id': 'OHSU FAMPLAN 3343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine group', 'description': 'Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization', 'interventionNames': ['Drug: Sterile Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'otherNames': ['Xylocaine'], 'description': '5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes', 'armGroupLabels': ['Lidocaine group']}, {'name': 'Sterile Saline', 'type': 'DRUG', 'description': '5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97206', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Planned Parenthood of the Columbia Willamette', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Michelle M. Isley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alison Edelman', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}