Outpatient Midline Catheter in Patients Receiveing Lidocaine Infusion Series.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Warsaw
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients qualified for lidocaine infusion therapy due to the chronic pain
Able to provide consent
≥18 years of age
Disqualifiers
Lack of patient consent
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Outpatient midline catheter
Trial outcomes
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.
Time frame
12 days (from midline insertion to the end of the therapy)Secondary outcomes
1
Midline Catheter Maintenance Duration
The total duration (in days) that each patient maintains a functional midline catheter without premature removal.
Time frame
12 days (from midline insertion to the end of the therapy)2
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.
Time frame
12 days (from midline insertion to the end of the therapy)3
A-DIVA scale score
A scale used for the assessment of predicted difficulties in securing difficult intravenous access.
Time frame
The onset of therapy4
Patient's satisfaction score
Patient satisfaction scores measured on a 0-10 scale
Time frame
12 days (from midline insertion to the end of the therapy)Sponsors and contacts
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Source ClinicalTrials.gov