Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter

Официальное название

Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Novel 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.
• Устройство Novel 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).

Первичные конечные точки

• Catheter Dislocation Distance [Срок оценки: From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).]

Вторичные конечные точки (7)

• Time on Task [Срок оценки: At time of procedure (Day 0)]
• Primary Placement Success Rate [Срок оценки: At time of procedure (Day 0)]
• Catheter Clinical Performance (Sensory Block) [Срок оценки: Day 0 (preprocedure and postprocedure), day 1, day 2, and day 3.]
• Catheter Retraction Force [Срок оценки: Day 3 (just before surgery)]
• Pain Intensity (NRS) [Срок оценки: Day 0, Day 1, Day 2 and Day 3]
• Cumulative Opioid Consumption [Срок оценки: Day 0 to day 3 (Entire study duration)]
• Incidence of Adverse Events [Срок оценки: Day 0 to day 3 (Entire study duration)]

Критерии участия

Критерии включения

• Adults aged 18 years or older
• Scheduled for elective transfemoral amputation
• Able and willing to provide informed consent

Критерии исключения

• Known allergy to local anesthetics

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Дания · 1 центр

• Hvidovre Hospital — Copenhagen

Публикации

• Carvalho BY, Mariano ER. Continuous vs. single-injection peripheral nerve blocks: A prospective cohort study comparing procedural time and personnel cost. Open Anesthesiol J. 2015;9:1-5.
• Martin N, Davis CJ. Evidence from masked-priming that initial identification of brand names is via abstract letter identities. Br J Psychol. 2019 Nov;110(4):745-768. doi: 10.1111/bjop.12362. Epub 2019 Jan 4. PMID 30613945
• Baillie J, Lankshear A. PATIENTS' AND RELATIVES' EXPERIENCES OF PERITONITIS WHEN USING PERITONEAL DIALYSIS. J Ren Care. 2015 Sep;41(3):177-86. doi: 10.1111/jorc.12118. Epub 2015 Feb 27. PMID 25727142
• Hauritz RW, Hannig KE, Balocco AL, Peeters G, Hadzic A, Borglum J, Bendtsen TF. Peripheral nerve catheters: A critical review of the efficacy. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):325-339. doi: 10.1016/j.bpa.2019.07.015. Epub 2019 Jul 22. PMID 31785718
• Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 Jan;124(1):308-335. doi: 10.1213/ANE.0000000000001581. PMID 27749354

Идентификаторы

NCT: NCT07385872 · Ethical Committee nr: 16098489

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗