Hvidovre Hospital
Copenhagen, Capital Region, Denmark
Not Yet Recruiting
NCT Number: NCT07385872
Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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).
Primary outcomes
-
Catheter Dislocation Distance
Time frame: 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.
Secondary outcomes
-
Time on Task
Time frame: At time of procedure (Day 0)
Time required for catheter placement, measured from initiation of skin disinfection to final skin fixation using a stopwatch (seconds).
-
Primary Placement Success Rate
Time frame: At time of procedure (Day 0)
Proportion of successful primary catheter placements, defined as the accurate position of the delivery orifice verified by ultrasound
-
Catheter Clinical Performance (Sensory Block)
Time frame: Day 0 (preprocedure and postprocedure), day 1, day 2, and day 3.
Sensitivity to a cooled vial (5°C) over the cutaneous innervation area (Tibial/Peroneal for sciatic; Saphenous for saphenous nerve).
-
Catheter Retraction Force
Time frame: Day 3 (just before surgery)
The force required for catheter removal, measured with a digital handheld force transducer (Newtons).
-
Pain Intensity (NRS)
Time frame: Day 0, Day 1, Day 2 and Day 3
Participant-reported pain at rest using a Numeric Rating Scale (0-10, where 0 is no pain and 10 the worst thinkable pain)
-
Cumulative Opioid Consumption
Time frame: Day 0 to day 3 (Entire study duration)
Total intravenous (IV) morphine equivalents administered while the catheter is in place.
-
Incidence of Adverse Events
Time frame: Day 0 to day 3 (Entire study duration)
Number and nature of complications including infection, back-leakage, or device-related issues.
Study contacts
Contact information is provided by the study sponsor or research team.
Christoffer C Jørgensen, MD, PhD
CONTACT
Kai H Lange, MD, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Nordsjaellands Hospital
Other
Collaborators
- Hvidovre University Hospital
- Nordstar Medical
Registry information
Official study title
Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Feb 4, 2026
- Registry last updated
- Feb 4, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.