Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks

NCT03667898 | Completed

• 1 other identifier: 2018/1100
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

In a randomized controlled crossover study design, ultrasound guided lumbar plexus blocks will be performed with and without the aid of a needle tip tracking (NTT) system. Specialists in anaesthesiology with average experience in ultrasound guided peripheral nerve block (PNB) techniques will perform the blocks. 27 volunteers will be included. The primary objective is to investigate the effect of the NTT system on performance time, as a measure for improved block performance. Secondary objectives are the effects of the NTT system on dexterity, peripheral nerve block characteristics, subjective experience, and peripheral block performance.

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

• Performance time

  Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection

  During peripheral nerve block procedure

Secondary Outcomes (9)

• Distance travelled by needling hand

  During peripheral nerve block procedure

• Distance travelled by probe hand

  During peripheral nerve block procedure

• Number of intended movements (needling hand)

  During peripheral nerve block procedure

• Number of intended movements (probe hand)

  During peripheral nerve block procedure

• Block success

  30 minutes after peripheral nerve block procedure

Study Arms (2)

Active needle tip tracking

EXPERIMENTAL

A needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.

Procedure: Lumbar plexus block using NTT

Inactive needle tip tracking

OTHER

No needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.

Procedure: Lumbar plexus block without NTT

Interventions

Lumbar plexus block using NTT PROCEDURE

An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.

Active needle tip tracking

Lumbar plexus block without NTT PROCEDURE

An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.

Inactive needle tip tracking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status 1 or 2
• Volunteers that have given informed written consent

You may not qualify if:

• BMI \< 18 kg/m2
• BMI \> 35 kg/m2
• Body weight \> 95 kg
• Volunteers that cannot cooperate during the examination
• Volunteers that do not speak or understand Norwegian language
• Volunteers with neurologic disease, nerve- or vascular impairment
• Volunteers with known coagulopathy
• Volunteers that are allergic to Lidocaine or other local anaesthetic agents
• Medications at the investigators discretion
• Volunteers with concomitant medical treatments interfering with PNB treatment
• Skin disease or infection affecting the whole-body surface or within the area of examination
• Any reason why, in the opinion of the investigators, the volunteer should not participate
• Subject participates in a potentially confounding drug or device trial during the course of the study
• Pregnancy and lactation period
• Women of childbearing potential who do not use an effective and secure method for birth control

Sponsors & Collaborators

• Oslo University Hospital: lead
• Philips Medical Systems: collaborator
• B. Braun Melsungen AG: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Investigator

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 12, 2018
• Study Start: October 8, 2018
• Primary Completion: October 26, 2018
• Study Completion: November 30, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

NO (1)