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.
Adults aged 18 years or older
Scheduled for elective transfemoral amputation
Able and willing to provide informed consent
Known allergy to local anesthetics
Sequential
Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve
DeviceA 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
DevicePlacement of the saphenous catheter is contingent upon an amputation line that allows for placement below the surgical site (distal to the cut).
Catheter Dislocation Distance
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.
Time on Task
Time required for catheter placement, measured from initiation of skin disinfection to final skin fixation using a stopwatch (seconds).
Primary Placement Success Rate
Proportion of successful primary catheter placements, defined as the accurate position of the delivery orifice verified by ultrasound
Catheter Clinical Performance (Sensory Block)
Sensitivity to a cooled vial (5°C) over the cutaneous innervation area (Tibial/Peroneal for sciatic; Saphenous for saphenous nerve).
Catheter Retraction Force
The force required for catheter removal, measured with a digital handheld force transducer (Newtons).
Click on the lead sponsor to view all of their trials.
Nordsjaellands Hospital
Lead sponsor
Hvidovre University Hospital
Collaborator
Nordstar Medical
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
