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:
Dokuz Eylul University
Organization:
Study Overview
Official Title:
Experimental Investigation of the Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus in a Patient-Controlled Analgesia (PCA) Model
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Study solutions were prepared as 100 mL each. Four groups were designed:
* Group 1: 0.125% levobupivacaine + 4 mL fentanyl (200 mcg)
* Group 2: 0.0625% levobupivacaine + 4 mL fentanyl (200 mcg)
* Group 3: 4 mL fentanyl (200 mcg)
* Group 4: 99 mL saline (control)
Each 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).
* Group 1: 0.125% levobupivacaine + 4 mL fentanyl (200 mcg)
* Group 2: 0.0625% levobupivacaine + 4 mL fentanyl (200 mcg)
* Group 3: 4 mL fentanyl (200 mcg)
* Group 4: 99 mL saline (control)
Each 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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DEU-Anaesthesia-Study-2010 | OTHER | Dokuz Eylul University Faculty of Medicine | View |