Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Series. (Midline Lid)

April 21, 2026 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Contact

Study Locations

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

Our study population is patients qualified for daily lidocaine infusion therapy for chronic pain. Patients are planned to receive an infusion daily for 10 days with 2 days weekend pause. The total therapy time is planned for 12 days.

Description

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

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
Outpatient midline catheter
Patients who receive a midline catheter for lidocaine infusion daily for ten days with two days weekend pause.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 days (from midline insertion to the end of the therapy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 days (from midline insertion to the end of the therapy)
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.
12 days (from midline insertion to the end of the therapy)
A-DIVA scale score
Time Frame: The onset of therapy
A scale used for the assessment of predicted difficulties in securing difficult intravenous access.
The onset of therapy
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
12 days (from midline insertion to the end of the therapy)
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.
12 days (from midline insertion to the end of the therapy)
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
12 days (from midline insertion to the end of the therapy)
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.
12 days (from midline insertion to the end of the therapy)
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.
12 days (from midline insertion to the end of the therapy)

Collaborators and Investigators

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

Sponsor

Medical University of Warsaw

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 (Estimated)

April 20, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2026

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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