Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT00768456
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2008-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '32 h'}], 'secondaryOutcomes': [{'measure': 'PONV', 'timeFrame': '32 h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy.\n\nThe hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* eligible for elective vaginal hysterectomy\n* able to speak and understand Danish\n* able to give informed consent\n\nExclusion Criteria:\n\n* alcohol or medical abuse\n* allergies to local anesthetics\n* age \\< 18 yrs.\n* intolerance to opioids'}, 'identificationModule': {'nctId': 'NCT00768456', 'briefTitle': 'Local Infiltration Analgesia With Ropivacaine Versus Placebo in Vaginal Hysterectomy: a Randomized, Double-Blind Study', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie', 'orgStudyIdInfo': {'id': 'H-C-2008-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Local infiltration with Ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.5 %']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Local infiltration with Placebo (NaCl)', 'interventionNames': ['Drug: Isotonic NaCl']}], 'interventions': [{'name': 'Ropivacaine 0.5 %', 'type': 'DRUG', 'description': 'Local Infiltration with Ropivacaine 0.5 %', 'armGroupLabels': ['1']}, {'name': 'Isotonic NaCl', 'type': 'DRUG', 'description': 'Local Infiltration with NaCl', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Copenhagen', 'state': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Billy B Kristensen', 'oldOrganization': 'Hvidovre University Hospital'}}}}