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

NCT07385872 | Not Yet Recruiting

• 1 other identifier: Ethical Committee nr: 16098489
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Condition: Catheter Displacement; Focus of Study: Sciatic Nerve; Primary Condition: Nerve Block

Keywords

Sciatic Nerve Block; Peripheral Nerve Catheter; Catheter Migration; Internal Fixation Device; Proof-of-Concept Study

Outcome Measures

Primary Outcomes (1)

• Catheter Dislocation Distance

  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.

  From initial placement (Day 0) to immediately prior to amputation surgery (typically 48-72 hours).

Secondary Outcomes (7)

• 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

Study Arms (2)

Sciatic Nerve Catheter

EXPERIMENTAL

All participants will receive the prototype fixation catheter placed near the sciatic nerve distal to the planned amputation line.

Device: Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve

Saphenous Nerve Catheter

EXPERIMENTAL

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.

Device: Novel Internal Fixation Nerve Block Catheter - Saphenous nerve

Interventions

Novel Internal Fixation Nerve Block Catheter - Saphenous nerve DEVICE

Placement of the saphenous catheter is contingent upon an amputation line that allows for placement below the surgical site (distal to the cut).

Saphenous Nerve Catheter

Novel Internal Fixation Nerve Block Catheter - Sciatic Nerve DEVICE

A peripheral nerve block catheter prototype featuring internal fixation to prevent dislocation and a rapid-deployment system. Catheters are placed under ultrasound guidance.

Sciatic Nerve Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known allergy to local anesthetics

Sponsors & Collaborators

• Hvidovre University Hospital: collaborator
• Nordstar Medical: collaborator
• Nordsjaellands Hospital: lead

Study Sites (1)

Hvidovre Hospital

Copenhagen, Capital Region, Denmark

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Christoffer C Jørgensen, MD, PhD

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoffer C Jørgensen, MD, PhD

CONTACT

+45 48296659; christoffer.calov.joergensen.01@regionh.dk

Kai H Lange, MD, PhD

CONTACT

+45 48294252; kai.henrik.wiborg.lange@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

DK (1)