Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Catheter Dislocation Distance
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Scheduled for elective transfemoral amputation
- •Able and willing to provide informed consent
排除标准
- •Known allergy to local anesthetics
研究组 & 干预措施
Sciatic Nerve Catheter
All participants will receive the prototype fixation catheter placed near the sciatic nerve distal to the planned amputation line.
干预措施: Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve (Device)
Saphenous Nerve Catheter
If the planned amputation line is high enough on the femur to allow for distal placement, participants will also receive a second prototype fixation catheter near the saphenous nerve.
干预措施: Novel Internal Fixation Nerve Block Catheter - Saphenous nerve (Device)
结局指标
主要结局
Catheter Dislocation Distance
时间窗: 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.
次要结局
- Time on Task(At time of procedure (Day 0))
- Primary Placement Success Rate(At time of procedure (Day 0))
- Catheter Clinical Performance (Sensory Block)(Day 0 (preprocedure and postprocedure), day 1, day 2, and day 3.)
- Catheter Retraction Force(Day 3 (just before surgery))
- Pain Intensity (NRS)(Day 0, Day 1, Day 2 and Day 3)
- Cumulative Opioid Consumption(Day 0 to day 3 (Entire study duration))
- Incidence of Adverse Events(Day 0 to day 3 (Entire study duration))