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Completed

NCT Number: NCT07285759

Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

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.

Fentanyl

Drug

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.

Saline

Other

Sterile saline solution (99 mL) used as the control group to compare antibacterial activity in the PCA infusion model.

Primary outcomes

  1. 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

  1. Morphological Changes of Staphylococcus aureus under SEM

    Time frame: 48

    Evaluation of ultrastructural changes in Staphylococcus aureus cells after exposure to levobupivacaine and fentanyl using Scanning Electron Microscope (SEM) imaging.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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