Chronic Pain, Lidocaine Infusion, Midline Catheter, Outpatient
Conditions
Keywords
midline catheter, lidocaine infusion, chronic pain, outpatient
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.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful lidocaine infusion therapy without the need for additional venous access | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Midline Catheter Maintenance Duration | 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. |
| Number of Participants with Premature Catheter Removal and Reasons | 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. |
| A-DIVA scale score | The onset of therapy | A scale used for the assessment of predicted difficulties in securing difficult intravenous access. |
| Patient's satisfaction score | 12 days (from midline insertion to the end of the therapy) | Patient satisfaction scores measured on a 0-10 scale |
| Number of catheter leakage events | 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. |
| Number of patients with phlebitis | 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 |
| Total number of upper extremity deep venous thrombosis events | 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. |
| Number of patients who requested catheter removal | 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. |
Countries
Poland