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NCT Number: NCT07242560

Epidural Catheter and Port-Related Infections in Pain Clinic Patients

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mersin University Faculty of Medicine, Department of Algology

Mersin, 33110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mesut Bakır

Other

Registry information

Official study title

Factors Associated With Infection Development in Epidural Catheter and Port Applications in a University Pain Clinic: A Retrospective Cohort Study

Important dates

Study start
2002
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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