Midline CatheterMidline LidNCT07555314
Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Series.
An observational study of Midline Catheter and Lidocaine Infusion, run by Medical University of Warsaw at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Midline Catheter, Lidocaine Infusion, Chronic Pain
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 20 Apr 2026to 1 Jun 2028
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients qualified for lidocaine infusion therapy due to the chronic pain
- Able to provide consent
- ≥18 years of age
Who cannot join
- Lack of patient consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Szpital Kliniczny Dzieciątka Jezus
Warsaw
Piotr Mieszczański, MD, +225021721, piotr.mieszczanski@wum.edu.pl
About this study
Official title: 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.
- Conditions
- Midline Catheter, Lidocaine Infusion, Chronic Pain, Outpatient
- Keywords
- midline catheter, lidocaine infusion, chronic pain, outpatient
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient midline catheter | Patients who receive a midline catheter for lidocaine infusion daily for ten days with two days weekend pause. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 days (from midline insertion to the end of the therapy)
Secondary outcomes (8)
Midline Catheter Maintenance Duration
The total duration (in days) that each patient maintains a functional midline catheter without premature removal.
Measured: 12 days (from midline insertion to the end of the therapy)
Number of Participants with Premature Catheter Removal and Reasons
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.
Measured: 12 days (from midline insertion to the end of the therapy)
A-DIVA scale score
A scale used for the assessment of predicted difficulties in securing difficult intravenous access.
Measured: The onset of therapy
Patient's satisfaction score
Patient satisfaction scores measured on a 0-10 scale
Measured: 12 days (from midline insertion to the end of the therapy)
Number of catheter leakage events
Catheter leakage events is defined as leakage of blood or fluids from the puncture site.
Measured: 12 days (from midline insertion to the end of the therapy)
Number of patients with phlebitis
Phlebitis is defined as infiltration/swelling or pain around the insertion site with medication or fluid administration
Measured: 12 days (from midline insertion to the end of the therapy)
Total number of upper extremity deep venous thrombosis events
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.
Measured: 12 days (from midline insertion to the end of the therapy)
Number of patients who requested catheter removal
The number of patients who requested catheter removal due to discomfort or other reasons.
Measured: 12 days (from midline insertion to the end of the therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start20 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Midline CatheterStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555314
- Sponsor's protocol ID
- 1/2026
- Acronym
- Midline Lid
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Therapy. A Prospective, Observational Study.
- ClinicalTrials.gov ID
- NCT07555314
- Acronym / sponsor ID
- Midline Lid / 1/2026
- Conditions
- Midline Catheter, Lidocaine Infusion, Chronic Pain, Outpatient
- Keywords
- midline catheter, lidocaine infusion, chronic pain, outpatient
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient midline catheter | – | –Patients who receive a midline catheter for lidocaine infusion daily for ten days with two days weekend pause. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients qualified for lidocaine infusion therapy due to the chronic pain
- Able to provide consent
- ≥18 years of age
Key exclusion criteria (1 listed)
- Lack of patient consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Midline Catheter Maintenance Duration
Time frame: 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)
A-DIVA scale score
Time frame: The onset of therapy
Patient's satisfaction score
Time frame: 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)
Number of patients with phlebitis
Time frame: 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)
Number of patients who requested catheter removal
Time frame: 12 days (from midline insertion to the end of the therapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
Related trials for Midline Catheter
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
Not yet recruitingObservational study
An Observational, Multinational, In Hospital Evaluation of Catheter Utilization Rates in Female Patients Using Indwelling Urinary Catheters and the PureWick™ Flex Female External Catheter Across Europe and the Middle East
Urinary Incontinence, Limited Mobility
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Active, not recruiting
Non-Invasive Median Nerve Stimulation to Attenuate Atrial Tachyarrhythmias After Catheter Ablation for Atrial Fibrillation
Atrial Fibrillation
Not yet recruiting
Immersive VR to Reduce Stress, Anxiety, and Pain During PICC/Midline Placement
Vasoconstriction, Biomarkers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Midline Catheter and Lidocaine Infusion, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piotr Mieszczański, MD (+48225021721, piotr.mieszczanski@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful lidocaine infusion therapy without the need for additional venous access (time frame: 12 days (from midline insertion to the end of the therapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.