Experimental Investigation of the Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus in a Patient-Controlled Analgesia (PCA) Model
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dokuz Eylul University
- Enrollment
- 40
- Primary Endpoint
- Reduction in Staphylococcus aureus Colony Count
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
No masking was performed. The study was conducted as an open-label in vitro experimental model.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Laboratory study using Staphylococcus aureus bacterial cultures.
- •Samples exposed to different concentrations of levobupivacaine and fentanyl solutions.
- •Controlled laboratory environment (Dokuz Eylül University, Microbiology Laboratory).
Exclusion Criteria
- •No human participants included.
- •No animal models used.
- •Studies outside the defined experimental conditions were excluded.
Arms & Interventions
Group 1 - 0.125% Levobupivacaine + Fentanyl
0.125% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.
Intervention: Levobupivacaine (Drug)
Group 1 - 0.125% Levobupivacaine + Fentanyl
0.125% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.
Intervention: Fentanyl (Drug)
Group 2 - 0.0625% Levobupivacaine + Fentanyl
0.0625% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.
Intervention: Levobupivacaine (Drug)
Group 2 - 0.0625% Levobupivacaine + Fentanyl
0.0625% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.
Intervention: Fentanyl (Drug)
Group 3 - Fentanyl Only
4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.
Intervention: Fentanyl (Drug)
Group 4 - Saline (Control)
99 mL saline infused via PCA system for 24 hours.
Intervention: Saline (Other)
Outcomes
Primary Outcomes
Reduction in Staphylococcus aureus Colony Count
Time Frame: 24 hours
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.
Secondary Outcomes
- Morphological Changes of Staphylococcus aureus under SEM(48)
Investigators
Gülay Akıncı
Dr. Gülay Akıncı, Department of Anesthesiology and Reanimation
Dokuz Eylul University