Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 1:32 PM
Study NCT ID:
NCT07285759
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010880', 'term': 'Piperidines'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking was performed. The study was conducted as an open-label in vitro experimental model.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Four independent groups were prepared using levobupivacaine and fentanyl at different concentrations and compared in parallel under in vitro laboratory conditions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Staphylococcus aureus Colony Count', 'timeFrame': '24 hours', 'description': 'Quantitative measurement of the antibacterial effect of levobupivacaine and fentanyl by counting Staphylococcus aureus colonies grown on Blood Agar after 24-hour PCA infusion at different concentrations.'}], 'secondaryOutcomes': [{'measure': 'Morphological Changes of Staphylococcus aureus under SEM', 'timeFrame': '48', 'description': 'Evaluation of ultrastructural changes in Staphylococcus aureus cells after exposure to levobupivacaine and fentanyl using Scanning Electron Microscope (SEM) imaging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Levobupivacaine', 'Antibacterial effect', 'Patient Controlled Analgesia (PCA)', 'Fentanyl', 'Scanning Electron Microscope (SEM)', 'Staphylococcus aureus'], 'conditions': ['Staphylococcus Aureus Bacterial Contamination']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://debis.deu.edu.tr/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This experimental in vitro study aimed to investigate the antibacterial effect of levobupivacaine on Staphylococcus aureus in a patient-controlled analgesia (PCA) model at concentrations commonly used for postoperative pain treatment (0.125%) and painless labour (0.0625%). The antibacterial activity was evaluated using colony count reduction and supported by Scanning Electron Microscope (SEM) imaging.', 'detailedDescription': 'Study solutions were prepared as 100 mL each. Four groups were designed:\n\n* Group 1: 0.125% levobupivacaine + 4 mL fentanyl (200 mcg)\n* Group 2: 0.0625% levobupivacaine + 4 mL fentanyl (200 mcg)\n* Group 3: 4 mL fentanyl (200 mcg)\n* Group 4: 99 mL saline (control)\n\nEach group received 1 mL of Staphylococcus aureus 0.5 McF (1.5×10⁸ cfu/mL). All samples were infused through a Portex bacterial filter at 4 mL/h for 24 hours using PCA devices. Samples collected from bottles, filter inlets, and outlets were cultivated on Blood Agar. Colony counts were compared statistically using the Kruskal-Wallis and Mann-Whitney U tests (p\\<0.05).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laboratory study using Staphylococcus aureus bacterial cultures.\n* Samples exposed to different concentrations of levobupivacaine and fentanyl solutions.\n* Controlled laboratory environment (Dokuz Eylül University, Microbiology Laboratory).\n\nExclusion Criteria:\n\n* No human participants included.\n* No animal models used.\n* Studies outside the defined experimental conditions were excluded.'}, 'identificationModule': {'nctId': 'NCT07285759', 'briefTitle': 'Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Experimental Investigation of the Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus in a Patient-Controlled Analgesia (PCA) Model', 'orgStudyIdInfo': {'id': 'DEU-LEVOBUPI-2010'}, 'secondaryIdInfos': [{'id': 'DEU-Anaesthesia-Study-2010', 'type': 'OTHER', 'domain': 'Dokuz Eylul University Faculty of Medicine'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - 0.125% Levobupivacaine + Fentanyl', 'description': '0.125% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.', 'interventionNames': ['Drug: Levobupivacaine', 'Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - 0.0625% Levobupivacaine + Fentanyl', 'description': '0.0625% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.', 'interventionNames': ['Drug: Levobupivacaine', 'Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3 - Fentanyl Only', 'description': '4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 4 - Saline (Control)', 'description': '99 mL saline infused via PCA system for 24 hours.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Levobupivacaine', 'type': 'DRUG', 'description': 'Levobupivacaine is a local anesthetic used at concentrations of 0.125% and 0.0625% to evaluate its antibacterial effect against Staphylococcus aureus in an in vitro PCA model.', 'armGroupLabels': ['Group 1 - 0.125% Levobupivacaine + Fentanyl', 'Group 2 - 0.0625% Levobupivacaine + Fentanyl']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl is an opioid analgesic used at a concentration of 200 mcg/4 mL, either alone or in combination with levobupivacaine, to assess potential contribution to antibacterial activity.', 'armGroupLabels': ['Group 1 - 0.125% Levobupivacaine + Fentanyl', 'Group 2 - 0.0625% Levobupivacaine + Fentanyl', 'Group 3 - Fentanyl Only']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Sterile saline solution (99 mL) used as the control group to compare antibacterial activity in the PCA infusion model.', 'armGroupLabels': ['Group 4 - Saline (Control)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gülay Akıncı', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylul University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because the study was completed in 2011 and data sharing was not included in the original ethics approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Gülay Akıncı, Department of Anesthesiology and Reanimation', 'investigatorFullName': 'Gülay Akıncı', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}