Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter

Nordsjaellands Hospital

Status: Not yet enrolling

Conditions: Focus of Study: Sciatic Nerve; Primary Condition: Nerve Block; Secondary Condition: Catheter Displacement

Treatments: Device: Novel Internal Fixation Nerve Block Catheter - Saphenous nerve; Device: Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve

Study type: Interventional

Funder types: Other

Identifiers

NCT07385872

Ethical Committee nr: 16098489

Details and patient eligibility

About

The goal of this study is to test a new type of nerve block catheter (a thin, flexible tube used to deliver pain medication). Researchers want to see if this new design stays in its original position better than current catheters and if it is easy for doctors to use.

The main questions the study aims to answer are:

Does the catheter tip stay in the correct position over time without moving or slipping (dislocation)?

Can the catheter be placed quickly and accurately using the new deployment system?

Researchers will test this prototype in a small group of participants. There is no comparison group for this initial study.

Participants will:

Have the catheter placed near a nerve in their leg a few days before a scheduled femoral (leg) amputation.

Undergo imaging or checks to see if the catheter has moved.

Have the catheter removed just before their scheduled surgery.

The catheter will be placed in an area of the leg that is already scheduled to be removed during surgery. This ensures that the study carries minimal risk to the participants.

Full description

Background and Rationale Peripheral nerve blocks are a standard of care for regional anesthesia; however, traditional catheters are prone to secondary dislocation (slipping out of place), which leads to inadequate pain control. This study evaluates a novel prototype catheter designed with an internal fixation mechanism intended to secure the catheter tip at the target site. Additionally, the system utilizes a refined deployment mechanism designed for rapid and precise placement by the clinician.

Study Objective The primary objective of this pilot study is to evaluate the stability and migration rate of the catheter tip over a multi-day period. Secondarily, the study will assess the technical feasibility and speed of the deployment system.

Study Design and Safety Model This is a single-arm, non-randomized, proof-of-concept trial. To ensure maximum participant safety during the testing of this new hardware, the study utilizes a femoral amputation model.

The catheter will be placed in participants who are already scheduled for a femoral amputation. The insertion site and the final position of the catheter tip will be located distal to (below) the anticipated surgical amputation line. This ensures that the tissue involved in the study is part of the limb intended for removal, thereby minimizing any long-term risk of nerve injury or local tissue complications for the participant.

Procedures

Baseline & Placement: Eligible participants will have the prototype catheter placed via ultrasound guidance several days prior to their scheduled surgery. The time required for deployment will be recorded.

Monitoring Period: The position of the catheter tip will be monitored at set intervals using ultrasound imaging to track any migration or dislocation from the initial placement site.

Removal: The catheter will be removed in the operating room immediately prior to the commencement of the scheduled amputation.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older
• Scheduled for elective transfemoral amputation
• Able and willing to provide informed consent

Exclusion criteria

• Known allergy to local anesthetics

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Sciatic Nerve Catheter

Experimental group

Description:

All participants will receive the prototype fixation catheter placed near the sciatic nerve distal to the planned amputation line.

Treatment:

Device: Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve

Saphenous Nerve Catheter

Experimental group

Description:

If the planned amputation line is high enough on the femur to allow for distal placement, participants will also receive a second prototype fixation catheter near the saphenous nerve.

Treatment:

Device: Novel Internal Fixation Nerve Block Catheter - Saphenous nerve