Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus

Experimental Investigation of the Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus in a Patient-Controlled Analgesia (PCA) Model

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus Bacterial Contamination
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Fentanyl; Other: Saline

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - 0.125% Levobupivacaine + Fentanyl; 0.125% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.	Drug: Levobupivacaine; 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.; Drug: Fentanyl; 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.
Experimental: Group 2 - 0.0625% Levobupivacaine + Fentanyl; 0.0625% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.	Drug: Levobupivacaine; 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.; Drug: Fentanyl; 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.
Active Comparator: Group 3 - Fentanyl Only; 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours.	Drug: Fentanyl; 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.
Placebo Comparator: Group 4 - Saline (Control); 99 mL saline infused via PCA system for 24 hours.	Other: Saline; Sterile saline solution (99 mL) used as the control group to compare antibacterial activity in the PCA infusion model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Staphylococcus aureus Colony Count	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphological Changes of Staphylococcus aureus under SEM	Evaluation of ultrastructural changes in Staphylococcus aureus cells after exposure to levobupivacaine and fentanyl using Scanning Electron Microscope (SEM) imaging.	48

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Gülay Akıncı, Dokuz Eylul University Faculty of Medicine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Fentanyl; Patient Controlled Analgesia (PCA); Levobupivacaine; Antibacterial effect; Scanning Electron Microscope (SEM)
• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Staphylococcal Infections; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Piperidines; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Bupivacaine; Levobupivacaine; Fentanyl; Sodium Chloride
• Other Study ID Numbers: DEU-LEVOBUPI-2010; DEU-Anaesthesia-Study-2010 (Other Identifier: Dokuz Eylul University Faculty of Medicine)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No