Performance of a Novel Concept for Internal Fixation of a Novel Peripheral Nerve Block Catheter
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve, Novel Internal Fixation Nerve Block Catheter - Saphenous nerve.
- Who it may be relevant to
- Registry conditions: Primary Condition: Nerve Block, Secondary Condition: Catheter Displacement, Focus of Study: Sciatic Nerve. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility and Performance of a Novel Concept for Internal Fixation of a Peripheral Nerve Block Catheter in Patients Undergoing Femoral Amputation
Overview
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
- Device 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. - Device 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).
Primary outcome measures
- Catheter Dislocation Distance [Time frame: From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).]
Secondary outcome measures (7)
- Time on Task [Time frame: At time of procedure (Day 0)]
- Primary Placement Success Rate [Time frame: At time of procedure (Day 0)]
- Catheter Clinical Performance (Sensory Block) [Time frame: Day 0 (preprocedure and postprocedure), day 1, day 2, and day 3.]
- Catheter Retraction Force [Time frame: Day 3 (just before surgery)]
- Pain Intensity (NRS) [Time frame: Day 0, Day 1, Day 2 and Day 3]
- Cumulative Opioid Consumption [Time frame: Day 0 to day 3 (Entire study duration)]
- Incidence of Adverse Events [Time frame: Day 0 to day 3 (Entire study duration)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 1 center
- Hvidovre Hospital — Copenhagen
Publications
- 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
Identifiers
NCT: NCT07385872 · Ethical Committee nr: 16098489