Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 8:56 AM
Study NCT ID:
NCT00771459
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2008-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2008-10-10', 'studyFirstSubmitQcDate': '2008-10-10', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '0-48 h postoperatively'}], 'secondaryOutcomes': [{'measure': 'Analgesia consumption', 'timeFrame': '0-48 h postoperatively'}]}, 'conditionsModule': {'keywords': ['Local infiltration analgesia', 'postoperative pain', 'ropivacaine'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients eligible for major spine surgery\n* must speak and understand Danish\n* must be able to give oral and written consent\n\nExclusion Criteria:\n\n* alcohol or medicine abuse\n* treatment with opioids \\> 100 mg daily\n* allergy to local anesthetics\n* severe obesity'}, 'identificationModule': {'nctId': 'NCT00771459', 'briefTitle': 'Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-kontrolleret Studie', 'orgStudyIdInfo': {'id': 'H-D-2007-0111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.5 %']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Isotonic NaCl']}], 'interventions': [{'name': 'Ropivacaine 0.5 %', 'type': 'DRUG', 'description': 'Local infiltration analgesia', 'armGroupLabels': ['Ropivacaine']}, {'name': 'Isotonic NaCl', 'type': 'DRUG', 'description': 'Local infiltration analgesia', 'armGroupLabels': ['Placebo']}]}, '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'}}}}