Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT03508804
Status:
WITHDRAWN
Last Update Posted:
2018-05-16
First Post:
2016-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-15', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perceived as measured by a Visual Analog Scale (0-100mm) at the time of cervical dilation', 'timeFrame': 'Intraoperative; Immediately following cervical dilation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical abortion', 'cervical anesthesia', 'pain control'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The investigators theorize that the application of a lidocaine-prilocaine cream 5-10 minutes prior to the administration of a paracervical block could decrease pain associated with its administration and pain with abortion overall.', 'detailedDescription': 'This is a superiority, double-blind randomized controlled trail of women ages 18 and older presenting for first-trimester surgical abortion. The lidocaine-prilocaine cream will be used in the experimental group in conjunction with a paracervical block, whereas plain lubricating gel will be used in conjunction with a paracervical block for the placebo, control group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgical abortion patient at 5 0/7 to 11 6/7 weeks gestational age;\n* English or Spanish speaking;\n* ability to give informed consent\n\nExclusion Criteria:\n\n* pre-operative use of misoprostol;\n* allergy to study medications (lidocaine, prilocaine, versed, fentanyl);\n* known uterine anomaly;\n* prior cervical surgery'}, 'identificationModule': {'nctId': 'NCT03508804', 'briefTitle': 'Lidocaine-Prilocaine Cream in Conjunction With Paracervical Block for Pain With Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Lidocaine-Prilocaine Cream in Conjunction With Lidocaine Paracervical Block for Pain With First-Trimester Abortion: A Double-Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB-38207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine-prilocaine cream', 'description': '5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the lidocaine-prilocaine cream vaginally using a syringe', 'interventionNames': ['Drug: Lidocaine-Prilocaine Cream', 'Drug: 1% Lidocaine Paracervical Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo cream (pain lucubrating gel)', 'description': '5-10 minutes prior to the start of the procedure, the participant will self-administer 10ml of the placebo cream vaginally using a syringe', 'interventionNames': ['Drug: Placebo Cream', 'Drug: 1% Lidocaine Paracervical Block']}], 'interventions': [{'name': 'Lidocaine-Prilocaine Cream', 'type': 'DRUG', 'otherNames': ['EMLA'], 'description': '10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine', 'armGroupLabels': ['Lidocaine-prilocaine cream']}, {'name': 'Placebo Cream', 'type': 'DRUG', 'description': '10ml of vaginally self-administered placebo cream', 'armGroupLabels': ['Placebo cream (pain lucubrating gel)']}, {'name': '1% Lidocaine Paracervical Block', 'type': 'DRUG', 'description': 'Paracervical block of 10ml of 1% lidocaine', 'armGroupLabels': ['Lidocaine-prilocaine cream', 'Placebo cream (pain lucubrating gel)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Principal Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}