Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-03-02 @ 10:04 PM
Study NCT ID:
NCT02852434
Status:
COMPLETED
Last Update Posted:
2019-06-07
First Post:
2016-06-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'familyplanningresearch@stanford.edu', 'phone': '6507211562', 'title': 'Stanford University, Department of OB/GYN', 'organization': 'Stanford University Division of Family Planning Services and Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 Day (day of procedure)', 'description': 'No data were collected following the day of procedure; Participants who completed the protocol are included in the analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)'}, {'id': 'OG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)'}], 'classes': [{'categories': [{'measurements': [{'value': '48.4', 'spread': '26', 'groupId': 'OG000'}, {'value': '56.3', 'spread': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative; Immediately (0-30 seconds) following cervical dilation', 'description': 'Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Anticipated Pain Measured by Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)'}, {'id': 'OG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)'}], 'classes': [{'categories': [{'measurements': [{'value': '47.2', 'spread': '22', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Preoperative; 30 minutes prior to procedure', 'description': 'Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Baseline Pain Measured by Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)'}, {'id': 'OG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '55', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately prior to procedure', 'description': 'Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Speculum Placement Measured by Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)'}, {'id': 'OG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'spread': '22', 'groupId': 'OG000'}, {'value': '31.2', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative; Immediately following speculum placement', 'description': 'Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis'}, {'type': 'SECONDARY', 'title': 'Overall Pain Measured by Visual Analogue Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)'}, {'id': 'OG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)'}], 'classes': [{'title': 'Overall Pain', 'categories': [{'measurements': [{'value': '45.4', 'spread': '26.7', 'groupId': 'OG000'}, {'value': '51.7', 'spread': '25.7', 'groupId': 'OG001'}]}]}, {'title': 'Overall Experience', 'categories': [{'measurements': [{'value': '65.2', 'spread': '30', 'groupId': 'OG000'}, {'value': '62.4', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Provider Reported Ease of Insertion', 'categories': [{'measurements': [{'value': '27', 'spread': '29', 'groupId': 'OG000'}, {'value': '21', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative; Assessed once 10 minutes after procedure', 'description': 'Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)'}, {'id': 'FG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Unsuccessful Dilator Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure\n\nLidocaine Gel (2%)'}, {'id': 'BG001', 'title': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement\n\nLidocaine Paracervical Block (1%)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '7.87', 'groupId': 'BG000'}, {'value': '27.2', 'spread': '7.14', 'groupId': 'BG001'}, {'value': '27.9', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational Age', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '23.4'}, {'value': '19.4', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '24'}, {'value': '19.2', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Participants who completed the protocol are included in the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-18', 'size': 207373, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-02-14T17:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2016-06-20', 'resultsFirstSubmitDate': '2018-03-16', 'studyFirstSubmitQcDate': '2016-08-01', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-16', 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion', 'timeFrame': 'Intraoperative; Immediately (0-30 seconds) following cervical dilation', 'description': 'Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.'}], 'secondaryOutcomes': [{'measure': 'Anticipated Pain Measured by Visual Analogue Scale', 'timeFrame': 'Preoperative; 30 minutes prior to procedure', 'description': 'Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.'}, {'measure': 'Baseline Pain Measured by Visual Analogue Scale', 'timeFrame': 'Immediately prior to procedure', 'description': 'Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.'}, {'measure': 'Speculum Placement Measured by Visual Analogue Scale', 'timeFrame': 'Intraoperative; Immediately following speculum placement', 'description': 'Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.'}, {'measure': 'Overall Pain Measured by Visual Analogue Scale', 'timeFrame': 'Postoperative; Assessed once 10 minutes after procedure', 'description': 'Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain Management, Cervical Preparation']}, 'referencesModule': {'references': [{'pmid': '30500336', 'type': 'DERIVED', 'citation': 'Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA. Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D\\&E) to paracervical block.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 and older\n* Intrauterine pregnancy ≥16 weeks gestation\n* English speaking competency\n* Willing and able to sign consent forms\n* Agree to comply with study procedures\n\nExclusion Criteria:\n\n* Women less than 18 years of age\n* IV conscious sedation\n* Known allergy to study medication (lidocaine)\n* Any women not meeting inclusion criteria above will be excluded from participation'}, 'identificationModule': {'nctId': 'NCT02852434', 'briefTitle': 'Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-38200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-administered Gel', 'description': 'Patient-administered, vaginal lidocaine gel (2%)--inserted 15 minutes prior to cervical preparation procedure', 'interventionNames': ['Drug: Lidocaine Gel (2%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paracervical Block', 'description': 'Provider-administered lidocaine (1%) paracervical injection--administered immediately prior to tenaculum placement', 'interventionNames': ['Drug: Lidocaine Paracervical Block (1%)']}], 'interventions': [{'name': 'Lidocaine Gel (2%)', 'type': 'DRUG', 'armGroupLabels': ['Self-administered Gel']}, {'name': 'Lidocaine Paracervical Block (1%)', 'type': 'DRUG', 'armGroupLabels': ['Paracervical Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Principal Investigator, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}