Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-06-20 @ 3:46 PM
Study NCT ID:
NCT02025166
Status:
UNKNOWN
Last Update Posted:
2013-12-31
First Post:
2013-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'C059451', 'term': 'lornoxicam'}], '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'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-30', 'studyFirstSubmitDate': '2013-12-23', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Two hours', 'description': 'Pain level will be evaluated by VAS'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'abortion', 'paracetamol', 'lornoxicam'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'To compare between the efficacy of Paracetamol IV vs. Lornoxicam IV in pain relief following surgical abortion.\n\nThe medication will be given at the time of the procedure. Following the abortion, pain level will be evaluated.', 'detailedDescription': 'Patients with medical indication for surgical abortion during first trimester will be divided to two groups. The study groups, the surgeons and the nurses will be blinded to one of the treatment arms.\n\nPain will be evaluated at fixed intervals following the abortion. Comparison in pain levels between the study groups will be analysed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective surgical abortion for first trimester pregnancy\n\nExclusion Criteria:\n\n* Chronic pelvic pain\n* Fibromyalgia\n* Pelvic inflammatory disease\n* Chronic renal failure, liver disease, peptic ulcer\n* cervical stenosis'}, 'identificationModule': {'nctId': 'NCT02025166', 'briefTitle': 'Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Comparison Between Two Analgesic Methods for Pain Relief Following Surgical Abortion', 'orgStudyIdInfo': {'id': 'RMB343-13'}, 'secondaryIdInfos': [{'id': 'RMB0343-13', 'type': 'OTHER', 'domain': 'Helsinki'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Paracetamol', 'description': 'Pain treatment, aniline analgesics', 'interventionNames': ['Drug: Paracetamol', 'Drug: lornoxicam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lornoxicam', 'description': 'Pain treatment, nonsteroidal anti-inflammatory (NSAID)', 'interventionNames': ['Drug: Paracetamol', 'Drug: lornoxicam']}], 'interventions': [{'name': 'Paracetamol', 'type': 'DRUG', 'otherNames': ['Pain relief'], 'description': 'Pain treatment with "aniline analgesics" (paracetamol) at the time of the procedure', 'armGroupLabels': ['Paracetamol', 'lornoxicam']}, {'name': 'lornoxicam', 'type': 'DRUG', 'otherNames': ['Pain relief'], 'description': 'Pain treatment with "NSAID" (lornoxicam) at the time of the procedure', 'armGroupLabels': ['Paracetamol', 'lornoxicam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'contacts': [{'name': 'Lior Lowenstein, MD, MS', 'role': 'CONTACT', 'email': 'l_lior@rambam.health.gov.il', 'phone': '972502061434'}, {'name': 'Susana Mustafa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Lior Lowenstein, MD, MS', 'role': 'CONTACT', 'email': 'l_lior@rambam.health.gov.il', 'phone': '97248542653'}], 'overallOfficials': [{'name': 'Susana Mustafa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Nibal Awad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gynecologist', 'investigatorFullName': 'Lior Lowenstein', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}