About this trial
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 criteria
Qualifiers
Adults aged 18 years or older
Scheduled for elective transfemoral amputation
Able and willing to provide informed consent
Disqualifiers
Known allergy to local anesthetics
Trial design
Treatments tested in this trial
- Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve
- Novel Internal Fixation Nerve Block Catheter - Saphenous nerve
Treatment groups
Sponsors and collaborators
Nordsjaellands Hospital
Lead sponsor
Hvidovre University Hospital
Collaborator
Nordstar Medical
Collaborator