- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242560
Epidural Catheter and Port-Related Infections in Pain Clinic Patients
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mersin
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Mersin, Mersin, Turkey (Türkiye), 33110
- Mersin University Faculty of Medicine, Department of Algology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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).
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From date of catheter or port placement until device removal or completion of follow-up (within study period January 2002-January 2025).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Risk Factors Associated With Infection Development
Time Frame: Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).
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Evaluation of demographic and procedural variables (e.g., catheter duration, insertion site, indication, comorbidities) and their association with infection occurrence.
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Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mesut Bakır, Assoc. Prof, Mersin University Faculty of Medicine, Pain Clinic
Publications and helpful links
General Publications
- Hebl JR, Niesen AD. Infectious Complications of Regional Anesthesia. Best Pract Res Clin Anaesthesiol. 2021;35(3):407-418. DOI: 10.1016/j.bpa.2021.05.003
- Domingues C, et al. Epidural Catheter Bacterial Colonization and Infection in a Secondary Portuguese Hospital Setting. Cureus. 2024;16(10):e72428. DOI: 10.7759/cureus.72428
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mersin-ALG-ECPI-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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