NCT07555314

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Apr 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress2%
Apr 2026Jun 2028

Study Start

First participant enrolled

April 20, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

Keywords

midline catheterlidocaine infusionchronic painoutpatient

Outcome Measures

Primary Outcomes (1)

  • Successful lidocaine infusion therapy without the need for additional venous access

    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 Outcomes (8)

  • Midline Catheter Maintenance Duration

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

  • Number of Participants with Premature Catheter Removal and Reasons

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

  • A-DIVA scale score

    The onset of therapy

  • Patient's satisfaction score

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

  • Number of catheter leakage events

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

  • +3 more secondary outcomes

Study Arms (1)

Outpatient midline catheter

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Lack of patient consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Szpital Kliniczny Dzieciątka Jezus

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Piotr Mieszczański, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 29, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations