Epidural Catheter and Port-Related Infections in Pain Clinic Patients

November 17, 2025 updated by: Mesut Bakır

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

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

Observational

Enrollment (Actual)

351

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Mersin
      • Mersin, Mersin, Turkey (Türkiye), 33110
        • Mersin University Faculty of Medicine, Department of Algology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From date of catheter or port placement until device removal or completion of follow-up (within study period January 2002-January 2025).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk Factors Associated With Infection Development
Time Frame: Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).
Evaluation of demographic and procedural variables (e.g., catheter duration, insertion site, indication, comorbidities) and their association with infection occurrence.
Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Mesut Bakır, Assoc. Prof, Mersin University Faculty of Medicine, Pain Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2002

Primary Completion (Actual)

January 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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