Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus

NCT07285759 | Completed

• 2 other identifiers: DEU-LEVOBUPI-2010DEU-Anaesthesia-Study-2010
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Staphylococcus Aureus Bacterial Contamination

Keywords

Levobupivacaine; Antibacterial effect; Patient Controlled Analgesia (PCA); Fentanyl; Scanning Electron Microscope (SEM); Staphylococcus aureus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Morphological Changes of Staphylococcus aureus under SEM

  48

Study Arms (4)

Group 1 - 0.125% Levobupivacaine + Fentanyl

EXPERIMENTAL

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

Drug: Levobupivacaine; Drug: Fentanyl

Group 2 - 0.0625% Levobupivacaine + Fentanyl

EXPERIMENTAL

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

Drug: Levobupivacaine; Drug: Fentanyl

Group 3 - Fentanyl Only

ACTIVE COMPARATOR

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

Drug: Fentanyl

Group 4 - Saline (Control)

PLACEBO COMPARATOR

99 mL saline infused via PCA system for 24 hours.

Other: Saline

Interventions

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.

Group 1 - 0.125% Levobupivacaine + Fentanyl; Group 2 - 0.0625% Levobupivacaine + Fentanyl

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.

Group 1 - 0.125% Levobupivacaine + Fentanyl; Group 2 - 0.0625% Levobupivacaine + Fentanyl; Group 3 - Fentanyl Only

Saline OTHER

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

Group 4 - Saline (Control)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• No human participants included.
• No animal models used.
• Studies outside the defined experimental conditions were excluded.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Related Links

• Related Info

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Levobupivacaine; Fentanyl; Sodium Chloride

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Gülay Akıncı

  Dokuz Eylul University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking was performed. The study was conducted as an open-label in vitro experimental model.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gülay Akıncı, Department of Anesthesiology and Reanimation

Model Details: Four independent groups were prepared using levobupivacaine and fentanyl at different concentrations and compared in parallel under in vitro laboratory conditions.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 16, 2025
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share