Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus

Dokuz Eylül University (DEU)

Status: Completed

Conditions: Staphylococcus Aureus Bacterial Contamination

Treatments: Other: Saline; Drug: Levobupivacaine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07285759

DEU-LEVOBUPI-2010

DEU-Anaesthesia-Study-2010 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups, including a placebo group

Group 1 - 0.125% Levobupivacaine + Fentanyl

Experimental group

Description:

0.125% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.

Treatment:

Drug: Fentanyl

Drug: Levobupivacaine

Group 2 - 0.0625% Levobupivacaine + Fentanyl

Experimental group

Description:

0.0625% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.

Treatment:

Drug: Fentanyl

Drug: Levobupivacaine

Group 3 - Fentanyl Only

Active Comparator group

Description:

4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.

Treatment:

Drug: Fentanyl

Group 4 - Saline (Control)

Placebo Comparator group

Description:

99 mL saline infused via PCA system for 24 hours.

Treatment:

Other: Saline