Intelligent Needle Tip Tracking Using Ultrasound Imaging for Infraclavicular Brachial Plexus Blocks

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2018-10-01

Brief Summary

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In a randomized controlled crossover study design, ultrasound guided infraclavicular brachial 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 PNB techniques will perform the blocks. 26 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.

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Detailed Description

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Conditions

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Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active needle tip tracking

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

Group Type ACTIVE_COMPARATOR

Infraclavicular brachial plexus block

Intervention Type PROCEDURE

An infraclavicular brachial plexus block is performed using ultrasound guidance.

Inactive needle tip tracking

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

Group Type OTHER

Infraclavicular brachial plexus block

Intervention Type PROCEDURE

An infraclavicular brachial plexus block is performed using ultrasound guidance.

Interventions

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Infraclavicular brachial plexus block

An infraclavicular brachial plexus block is performed using ultrasound guidance.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ASA physical status 1 or 2
* Volunteers that have given informed written consent

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes