Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-04-20 @ 12:36 PM
Study NCT ID:
NCT02007408
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000773', 'term': 'Anesthesia, Obstetrical'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores on the Visual Analog Scale', 'timeFrame': 'Three months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['abortion', 'analgesia', 'paracervical block', 'lidocaine spray'], 'conditions': ['Pain Score']}, 'descriptionModule': {'briefSummary': 'Objective: The investigators sought to investigate the analgesic efficiency of lidocaine spray, paracervical block (PCB) with lidocaine and PCB with lidocaine plus lidocaine spray combination in patients undergoing first-trimester surgical abortion.\n\nMethods: A randomized, double-blind, placebo-controlled clinical trial was conducted on 108 women with the request of pregnancy termination.The subjects were randomly assigned into four groups: PCB (n=27), lidocaine spray (n=27), PCB plus lidocaine spray (n=27) and placebo(n=27).Intraoperative and postoperative pain scores were measured with a standard Visual Analog Scale (VAS).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge \\>18 years Single Pregnancy \\<7 weeks of gestation\n\nExclusion Criteria:\n\nIncomplete abortion Early pregnancy failure Acute cervicitis Untreated pelvic inflammatory disease Cervical stenosis'}, 'identificationModule': {'nctId': 'NCT02007408', 'briefTitle': 'Comparison of Lidocaine Spray and Paracervical Block Application for Pain Relief During First-trimester Surgical Abortion: a Randomized, Double-blind, Placebo-controlled Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kayseri Education and Research Hospital'}, 'orgStudyIdInfo': {'id': 'KERH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paracervical block plus lidocaine spray', 'description': 'Lidocaine injection+Lidocaine spray received PCB with 2 ampoules of lidocaine solution plus 2 pumps (20 mg=2 pumps) of 10% lidocaine spray', 'interventionNames': ['Drug: Paracervical block + lidocaine spray']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'paracervical block plus isotonic saline spray', 'description': '2 ampoules of lidocaine solution (20 mg Lidocaine HCl+0.0125 mg epinephrine/ml) plus isotonic spray', 'interventionNames': ['Drug: Paracervical block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'only lidocaine spray', 'description': 'paracervical block with saline solution plus 10% lidocaine spray', 'interventionNames': ['Drug: Lidocaine spray']}], 'interventions': [{'name': 'Paracervical block', 'type': 'DRUG', 'armGroupLabels': ['paracervical block plus isotonic saline spray']}, {'name': 'Lidocaine spray', 'type': 'DRUG', 'armGroupLabels': ['only lidocaine spray']}, {'name': 'Paracervical block + lidocaine spray', 'type': 'DRUG', 'armGroupLabels': ['Paracervical block plus lidocaine spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38010', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Gökhan Açmaz', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kayseri Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Gökhan Açmaz', 'investigatorAffiliation': 'Kayseri Education and Research Hospital'}}}}