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Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus

NCT ID: NCT07285759

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-02-28

Brief Summary

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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

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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).

Conditions

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Staphylococcus Aureus Bacterial Contamination

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Four independent groups were prepared using levobupivacaine and fentanyl at different concentrations and compared in parallel under in vitro laboratory conditions.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

No masking was performed. The study was conducted as an open-label in vitro experimental model.

Study Groups

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Group 1 - 0.125% Levobupivacaine + Fentanyl

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

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type 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

Intervention Type 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 2 - 0.0625% Levobupivacaine + Fentanyl

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

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type 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

Intervention Type 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 3 - Fentanyl Only

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type 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 4 - Saline (Control)

99 mL saline infused via PCA system for 24 hours.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Saline

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

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Gülay Akıncı

Dr. Gülay Akıncı, Department of Anesthesiology and Reanimation

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülay Akıncı

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University Faculty of Medicine

Related Links

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https://debis.deu.edu.tr/

Related Info

Other Identifiers

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DEU-Anaesthesia-Study-2010

Identifier Type: OTHER

Identifier Source: secondary_id

DEU-LEVOBUPI-2010

Identifier Type: -

Identifier Source: org_study_id