Epidural Catheter-Related InfectionNCT07242560
Epidural Catheter and Port-Related Infections in Pain Clinic Patients
An observational study of Epidural Catheter-Related Infection and Hospital-Acquired Infection, run by Mesut Bakır at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to evaluate the incidence and risk factors of infection associated with epidural catheter and port applications performed in the Pain Clinic of Mersin University Faculty of Medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epidural Catheter-Related Infection, Hospital-Acquired Infection, Procedural Complication
- How many people
- 351 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2002to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at the Pain Clinic of Mersin University Faculty of Medicine who received epidural catheter or port applications for pain management between 2002 and 2025.
Who may be able to join
- Patients aged 18 years and older.
- Patients who underwent epidural catheter or epidural port application at Mersin University Pain Clinic between January 1, 2002 and January 1, 2025.
- Complete clinical records including demographic data, procedural details, and culture results available for review.
Who cannot join
- Patients with incomplete or missing procedural or infection data.
- Patients whose records do not include culture or infection status documentation.
- Patients younger than 18 years old.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Faculty of Medicine, Department of Algology
Mersin, Mersin, 33110
About this study
Official title: Factors Associated With Infection Development in Epidural Catheter and Port Applications in a University Pain Clinic: A Retrospective Cohort Study
This retrospective observational study aims to evaluate the incidence and risk factors of infection associated with epidural catheter and port applications performed in the Pain Clinic of Mersin University Faculty of Medicine. Data from patients who underwent epidural catheter or port placement between January 2002 and January 2025 will be analyzed.
Demographic data, catheter duration, insertion level, type of device, clinical indication, and microbiological culture results will be examined to determine factors influencing infection development. The study seeks to identify common pathogens and assess potential relationships between procedural characteristics and infection risk.
The ultimate goal of this research is to contribute to improving infection prevention strategies and ensuring patient safety in interventional pain management practices.
Read the detailed description
This retrospective cohort study investigates the factors associated with infection development following epidural catheter and port applications performed in the Pain Clinic of Mersin University Faculty of Medicine between January 2002 and January 2022. Data collection has been completed, and the final data analysis is expected to be finalized by November 30, 2025.
Epidural catheterization and port placement are frequently performed interventional pain management procedures used for postoperative and chronic cancer pain treatment. Despite their clinical utility, these procedures carry a risk of infection that can lead to serious complications, including epidural abscess, meningitis, or systemic sepsis.
The study retrospectively reviews 351 cases from institutional archives. Demographic data (age, sex, diagnosis), procedural details (catheter duration, insertion level, anatomical site, indication, brand), and infection outcomes (presence of infection, culture results, and isolated microorganisms) are analyzed.
Primary outcome is the incidence of infection associated with epidural catheter or port use. Secondary outcomes include identifying risk factors such as catheter duration, insertion site, clinical indication, and the distribution of isolated pathogens. Statistical analyses are conducted using appropriate parametric or non-parametric tests, and p < 0.05 is considered significant.
The findings of this study are expected to contribute to improving infection prevention strategies and clinical protocols for safer interventional pain management practices.
- Keywords
- Epidural catheter, Epidural port, Infection, Pain clinic, Interventional pain management
- Medical subject headings
- Cross Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Catheter Group | Patients who underwent epidural catheter insertion for pain management between January 2002 and December 2022 at the Mersin University Pain Clinic. Data include catheter duration, insertion site, indication, and culture results. | |
| Epidural Port Group | Patients who received epidural port placement for long-term analgesic management during the same period. Data include port type, indication, duration of use, and infection outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Infection Associated With Epidural Catheter or Port Use
The proportion of patients who developed infection following epidural catheter or port placement, confirmed either clinically or microbiologically (positive culture from catheter tip or port site).
Measured: From date of catheter or port placement until device removal or completion of follow-up (within study period January 2002-January 2025).
Secondary outcomes (1)
Risk Factors Associated With Infection Development
Evaluation of demographic and procedural variables (e.g., catheter duration, insertion site, indication, comorbidities) and their association with infection occurrence.
Measured: Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jan 2002
- Primary completion1 Jan 2025
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Epidural Catheter-Related InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mesut Bakır
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mesut Bakır, Mersin University
- Investigators
- Mesut Bakır, Assoc. Prof, Principal investigator, Mersin University Faculty of Medicine, Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242560
- Sponsor's protocol ID
- Mersin-ALG-ECPI-2025
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a retrospective study based on de-identified patient records. No individual participant data (IPD) will be shared. Only aggregated results may be published in scientific journals.
Publications
Horlocker TT, Wedel DJ. Infectious complications of regional anesthesia. Best Pract Res Clin Anaesthesiol. 2008 Sep;22(3):451-75. doi: 10.1016/j.bpa.2008.06.003.
PubMed 18831298Domingues C, Goncalves L, Laranjo M, Santos T, Goncalves D, Goncalves L, Barros AC, Marrao G, Castro R, Valente E. Epidural Catheter Bacterial Colonization and Infection in a Secondary Portuguese Hospital Setting. Cureus. 2024 Oct 26;16(10):e72428. doi: 10.7759/cureus.72428. eCollection 2024 Oct.
PubMed 39588402
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Infection Development in Epidural Catheter and Port Applications in a University Pain Clinic: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07242560
- Acronym / sponsor ID
- Mersin-ALG-ECPI-2025
- Keywords
- Epidural catheter, Epidural port, Infection, Pain clinic, Interventional pain management
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Mesut BakırUniversity, hospital or other
- Study start
- 1 Jan 2002 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 21 Nov 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 retrospective observational study aims to evaluate the incidence and risk factors of infection associated with epidural catheter and port applications performed in the Pain Clinic of Mersin University Faculty of Medicine. Data from patients who underwent epidural catheter or port placement between January 2002 and January 2025 will be analyzed.
Demographic data, catheter duration, insertion level, type of device, clinical indication, and microbiological culture results will be examined to determine factors influencing infection development. The study seeks to identify common pathogens and assess potential relationships between procedural characteristics and infection risk.
The ultimate goal of this research is to contribute to improving infection prevention strategies and ensuring patient safety in interventional pain management practices.
Detailed description
This retrospective cohort study investigates the factors associated with infection development following epidural catheter and port applications performed in the Pain Clinic of Mersin University Faculty of Medicine between January 2002 and January 2022. Data collection has been completed, and the final data analysis is expected to be finalized by November 30, 2025.
Epidural catheterization and port placement are frequently performed interventional pain management procedures used for postoperative and chronic cancer pain treatment. Despite their clinical utility, these procedures carry a risk of infection that can lead to serious complications, including epidural abscess, meningitis, or systemic sepsis.
The study retrospectively reviews 351 cases from institutional archives. Demographic data (age, sex, diagnosis), procedural details (catheter duration, insertion level, anatomical site, indication, brand), and infection outcomes (presence of infection, culture results, and isolated microorganisms) are analyzed.
Primary outcome is the incidence of infection associated with epidural catheter or port use. Secondary outcomes include identifying risk factors such as catheter duration, insertion site, clinical indication, and the distribution of isolated pathogens. Statistical analyses are conducted using appropriate parametric or non-parametric tests, and p < 0.05 is considered significant.
The findings of this study are expected to contribute to improving infection prevention strategies and clinical protocols for safer interventional pain management practices.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Catheter Group | – | –Patients who underwent epidural catheter insertion for pain management between January 2002 and December 2022 at the Mersin University Pain Clinic. Data include catheter duration, insertion site, indication, and culture results. |
| Epidural Port Group | – | –Patients who received epidural port placement for long-term analgesic management during the same period. Data include port type, indication, duration of use, and infection outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at the Pain Clinic of Mersin University Faculty of Medicine who received epidural catheter or port applications for pain management between 2002 and 2025.
Key inclusion criteria (3 listed)
- Patients aged 18 years and older.
- Patients who underwent epidural catheter or epidural port application at Mersin University Pain Clinic between January 1, 2002 and January 1, 2025.
- Complete clinical records including demographic data, procedural details, and culture results available for review.
Key exclusion criteria (3 listed)
- Patients with incomplete or missing procedural or infection data.
- Patients whose records do not include culture or infection status documentation.
- Patients younger than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Infection Associated With Epidural Catheter or Port Use
Time frame: From date of catheter or port placement until device removal or completion of follow-up (within study period January 2002-January 2025).
The proportion of patients who developed infection following epidural catheter or port placement, confirmed either clinically or microbiologically (positive culture from catheter tip or port site).
1 secondary outcome
Risk Factors Associated With Infection Development
Time frame: Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Background: PubMed 18831298Horlocker TT, Wedel DJ. Infectious complications of regional anesthesia. Best Pract Res Clin Anaesthesiol. 2008 Sep;22(3):451-75. doi: 10.1016/j.bpa.2008.06.003.
- Background: PubMed 39588402Domingues C, Goncalves L, Laranjo M, Santos T, Goncalves D, Goncalves L, Barros AC, Marrao G, Castro R, Valente E. Epidural Catheter Bacterial Colonization and Infection in a Secondary Portuguese Hospital Setting. Cureus. 2024 Oct 26;16(10):e72428. doi: 10.7759/cureus.72428. eCollection 2024 Oct.
- Individual participant dataSharing planned: No. This is a retrospective study based on de-identified patient records. No individual participant data (IPD) will be shared. Only aggregated results may be published in scientific journals.
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.
Mesut Bakır, Assoc. Prof principal investigator
Mersin University Faculty of Medicine, Pain Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural Catheter-Related Infection and Hospital-Acquired Infection, run by Mesut Bakır at 1 site in Turkey (Türkiye).
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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Infection Associated With Epidural Catheter or Port Use (time frame: From date of catheter or port placement until device removal or completion of follow-up (within study period January 2002-January 2025).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07242560, which also lists 2 linked publications.
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 21 Nov 2025.