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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient midline catheter | Patients who receive a midline catheter for lidocaine infusion daily for ten days with two days weekend pause. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Midline Catheter Maintenance Duration | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Mieszczański, MD | Contact | +48225021721 | piotr.mieszczanski@wum.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szpital Kliniczny Dzieciątka Jezus | Recruiting | Warsaw | Poland |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 | A scale used for the assessment of predicted difficulties in securing difficult intravenous access. | The onset of therapy |
| Patient's satisfaction score | 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 | 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 | 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 | 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 | 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) |