NCT07242560

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
23 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 21, 2025

Status Verified

October 1, 2025

Enrollment Period

23 years

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Epidural catheterEpidural portInfectionPain clinicInterventional pain management

Outcome Measures

Primary Outcomes (1)

  • 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).

    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

    Throughout the duration of catheter or port use, within the study period (January 2002-January 2025).

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Medicine, Department of Algology

Mersin, Mersin, 33110, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 18831298BACKGROUND
  • Domingues 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.

    PMID: 39588402BACKGROUND

MeSH Terms

Conditions

Cross InfectionInfections

Condition Hierarchy (Ancestors)

Iatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mesut Bakır, Assoc. Prof

    Mersin University Faculty of Medicine, Pain Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof. Dr. Mesut Bakır, Mersin University Faculty of Medicine, Department of Algology

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 21, 2025

Study Start

January 1, 2002

Primary Completion

January 1, 2025

Study Completion

December 1, 2025

Last Updated

November 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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.

Locations