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NCT Number: NCT07555314

Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Series.

This study will assess the efficacy, safety and practicality of using midline catheters for repeated intravenous lidocaine infusions in an outpatient pain management setting. Adult patients requiring serial lidocaine infusions for chronic pain will be enrolled and receive treatment through midline catheters over ten sessions.

The study will investigate if the midline catheters are a safe and effective option for delivering repeated lidocaine infusions in the outpatient setting, offering a balance between ease of placement, acceptable complication risk and good patients' comfort.

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Key information

Conditions

Midline Catheter Chronic Pain Lidocaine Infusion Neurologic Manifestations Outpatient Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Szpital Kliniczny Dzieciątka Jezus

Warsaw, Poland

Location status: Recruiting

Location contact

Piotr Mieszczański, MD

CONTACT

[email protected]

+225021721

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients qualified for lidocaine infusion therapy due to the chronic pain
  • Able to provide consent
  • ≥18 years of age

Exclusion criteria

  • Lack of patient consent

Treatment and study plan

Primary outcomes

  1. Successful lidocaine infusion therapy without the need for additional venous access

    Time frame: 12 days (from midline insertion to the end of the therapy)

    Percentage of patients who received a daily lidocaine infusion for 10 days with a 2-day pause in an outpatient setting who did not require additional venous access.

Secondary outcomes

  1. Midline Catheter Maintenance Duration

    Time frame: 12 days (from midline insertion to the end of the therapy)

    The total duration (in days) that each patient maintains a functional midline catheter without premature removal.

  2. Number of Participants with Premature Catheter Removal and Reasons

    Time frame: 12 days (from midline insertion to the end of the therapy)

    The primary reason for premature catheter removal will be documented, including: occlusion, inadvertent removal, extravasation, suspected infection, confirmed infection, thrombosis, catheter malfunction, phlebitis, or removal at the patient's request.

  3. A-DIVA scale score

    Time frame: The onset of therapy

    A scale used for the assessment of predicted difficulties in securing difficult intravenous access.

  4. Patient's satisfaction score

    Time frame: 12 days (from midline insertion to the end of the therapy)

    Patient satisfaction scores measured on a 0-10 scale

  5. Number of catheter leakage events

    Time frame: 12 days (from midline insertion to the end of the therapy)

    Catheter leakage events is defined as leakage of blood or fluids from the puncture site.

  6. Number of patients with phlebitis

    Time frame: 12 days (from midline insertion to the end of the therapy)

    Phlebitis is defined as infiltration/swelling or pain around the insertion site with medication or fluid administration

  7. Total number of upper extremity deep venous thrombosis events

    Time frame: 12 days (from midline insertion to the end of the therapy)

    This is defined as symptomatic or asymptomatic DVT, verified by ultrasound or computed tomography. The total number of upper extremity DVT events will be recorded by study arm.

  8. Number of patients who requested catheter removal

    Time frame: 12 days (from midline insertion to the end of the therapy)

    The number of patients who requested catheter removal due to discomfort or other reasons.

Study contacts

Contact information is provided by the study sponsor or research team.

Piotr Mieszczański, MD

CONTACT

[email protected]

+48225021721

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Therapy. A Prospective, Observational Study.

Acronym: Midline Lid

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

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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