Focus of Study: Sciatic Nerve, Primary Condition: Nerve Block, Secondary Condition: Catheter Displacement
Conditions
Keywords
Sciatic Nerve Block, Peripheral Nerve Catheter, Catheter Migration, Internal Fixation Device, Proof-of-Concept Study
Brief 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.
Detailed 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.
Interventions
DEVICENovel 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.
DEVICENovel 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).
Sponsors
Nordsjaellands Hospital
Hvidovre University Hospital
Nordstar Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time on Task | 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 | 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) | 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 | Day 3 (just before surgery) | The force required for catheter removal, measured with a digital handheld force transducer (Newtons). |
| Pain Intensity (NRS) | 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 | Day 0 to day 3 (Entire study duration) | Total intravenous (IV) morphine equivalents administered while the catheter is in place. |
| Incidence of Adverse Events | Day 0 to day 3 (Entire study duration) | Number and nature of complications including infection, back-leakage, or device-related issues. |
Countries
Denmark
Contacts
CONTACTChristoffer C Jørgensen, MD, PhD
CONTACTKai H Lange, MD, PhD
PRINCIPAL_INVESTIGATORChristoffer C Jørgensen, MD, PhD
Nordsjaellands Hospital
Outcome results
None listed