Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-03-02 @ 10:35 PM
Study NCT ID:
NCT02561468
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2015-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Preemptive Analgesic Efficacy of Nefopam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009340', 'term': 'Nefopam'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D010079', 'term': 'Oxazocines'}, {'id': 'D001392', 'term': 'Azocines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2015-08-03', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of pain numerical rating score from postoperative 30 min until postoperative 3 month', 'timeFrame': 'Postoperative 30 min, postoperative 1 day, postoperative 1 week, postoperative 3 month'}], 'secondaryOutcomes': [{'measure': 'The dose of ketorolac administered to the patient.', 'timeFrame': 'postoperative 1 day'}]}, 'conditionsModule': {'conditions': ['Breast Neoplasm']}, 'descriptionModule': {'briefSummary': 'Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be reduced.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with breast cancer\n* Lumpectomy with axillary lymph node dissection or Lumpectomy with sentinel lymph node biopsy\n* American Society of Anesthesiologists physical status I or II\n\nExclusion Criteria:\n\n* Refusal\n* Seizure\n* Cardiac disease\n* Monoamine oxidase inhibitor user\n* Urologic disease\n* Glucoma\n* Preoperative analgesic drug medication\n* Pregnancy\n* Recurred breast cancer patient'}, 'identificationModule': {'nctId': 'NCT02561468', 'briefTitle': 'The Preemptive Analgesic Efficacy of Nefopam', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'orgStudyIdInfo': {'id': 'Nefo_breast cancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nefopam', 'description': '20 mg nefopam in 100 ml normal saline is infused before starting operation.', 'interventionNames': ['Drug: Nefopam']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '100 ml normal saline is infused before starting operation.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Nefopam', 'type': 'DRUG', 'armGroupLabels': ['Nefopam']}, {'name': 'Saline', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-607', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Hyo-Seok Na', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}