Epidural Catheter and Port-Related Infections in Pain Clinic Patients

NCT ID: NCT07242560

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Epidural Catheter-Related Infection Hospital-Acquired Infection Procedural Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mesut Bakır

OTHER

Sponsor Role lead

Responsible Party

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Mesut Bakır

Assoc. Prof. Dr. Mesut Bakır, Mersin University Faculty of Medicine, Department of Algology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mesut Bakır, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Mersin University Faculty of Medicine, Pain Clinic

Locations

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Mersin University Faculty of Medicine, Department of Algology

Mersin, Mersin, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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Mersin-ALG-ECPI-2025

Identifier Type: -

Identifier Source: org_study_id

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