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

Condition(s) studied

Investigational drug(s) / intervention(s)

Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve: A peripheral nerve block catheter prototype featuring internal fixation to prevent dislocation and a rapid-deployment system. Catheters are placed under ultrasound guidance.

Novel Internal Fixation Nerve Block Catheter - Saphenous nerve: Placement of the saphenous catheter is contingent upon an amputation line that allows for placement below the surgical site (distal to the cut).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Catheter Dislocation Distance — From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).
  The absolute distance (in millimeters) between the position of the catheter delivery orifice at initial placement and its position just before removal. The position is verified by ultrasound imaging using hydrodissection with a local anesthetic bolus to identify the orifice.

Trial sites (1)

More Nordsjaellands Hospital trials in Denmark