Staphylococcus Aureus Bacterial ContaminationNCT07285759
Investigation of Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus
A study testing Levobupivacaine, Fentanyl and Saline in people with Staphylococcus Aureus Bacterial Contamination, run by Dokuz Eylul University.
Trial 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%). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcus Aureus Bacterial Contamination
- What is being tested?
- Levobupivacaine, Fentanyl and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- No human participants included.
- No animal models used.
- Studies outside the defined experimental conditions were excluded.
About this study
Official title: 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.
Read the 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).
- Being tested
- Levobupivacaine, Fentanyl, Saline
- Keywords
- Levobupivacaine, Antibacterial effect, Patient Controlled Analgesia (PCA), Fentanyl, Scanning Electron Microscope (SEM), Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
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.
FentanylDrug
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.
SalineOther
Sterile saline solution (99 mL) used as the control group to compare antibacterial activity in the PCA infusion model.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - 0.125% Levobupivacaine + Fentanyl | Experimental | 0.125% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours. Receives: 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. Receives: Drug: Levobupivacaine; Drug: Fentanyl |
| Group 3 - Fentanyl Only | Active comparator | 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours. Receives: Drug: Fentanyl |
| Group 4 - Saline (Control) | Placebo comparator | 99 mL saline infused via PCA system for 24 hours. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study startNov 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus Bacterial ContaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Four independent groups were prepared using levobupivacaine and fentanyl at different concentrations and compared in parallel under in vitro laboratory conditions.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Akıncı, Dokuz Eylul University
- Investigators
- Gülay Akıncı, Principal investigator, Dokuz Eylul University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285759
- Sponsor's protocol ID
- DEU-LEVOBUPI-2010
- Other IDs
- DEU-Anaesthesia-Study-2010
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Investigation of the Antibacterial Effect of Levobupivacaine on Staphylococcus Aureus in a Patient-Controlled Analgesia (PCA) Model
- ClinicalTrials.gov ID
- NCT07285759
- Acronym / sponsor ID
- DEU-LEVOBUPI-2010
- Keywords
- Levobupivacaine, Antibacterial effect, Patient Controlled Analgesia (PCA), Fentanyl, Scanning Electron Microscope (SEM), Staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Four independent groups were prepared using levobupivacaine and fentanyl at different concentrations and compared in parallel under in vitro laboratory conditions.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - 0.125% Levobupivacaine + Fentanyl | Experimental | Drug: Levobupivacaine, Drug: Fentanyl0.125% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours. |
| Group 2 - 0.0625% Levobupivacaine + Fentanyl | Experimental | Drug: Levobupivacaine, Drug: Fentanyl0.0625% levobupivacaine with 4 mL fentanyl (200 mcg) infused via PCA system for 24 hours. |
| Group 3 - Fentanyl Only | Active comparator | Drug: Fentanyl4 mL fentanyl (200 mcg) infused via PCA system for 24 hours. |
| Group 4 - Saline (Control) | Placebo comparator | Other: Saline99 mL saline infused via PCA system for 24 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- No human participants included.
- No animal models used.
- Studies outside the defined experimental conditions were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevobupivacaineLevobupivacaine 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 | Group 1 - 0.125% Levobupivacaine + Fentanyl, Group 2 - 0.0625% Levobupivacaine + Fentanyl |
| FentanylFentanyl 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. | Drug | Group 1 - 0.125% Levobupivacaine + Fentanyl, Group 2 - 0.0625% Levobupivacaine + Fentanyl, Group 3 - Fentanyl Only |
| SalineSterile saline solution (99 mL) used as the control group to compare antibacterial activity in the PCA infusion model. | Other | Group 4 - Saline (Control) |
Primary outcome
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.
1 secondary outcome
Morphological Changes of Staphylococcus aureus under SEM
Time frame: 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülay Akıncı principal investigator
Dokuz Eylul University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine, Fentanyl and Saline in people with Staphylococcus Aureus Bacterial Contamination, run by Dokuz Eylul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Staphylococcus aureus Colony Count (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.