Clinical trial NCT03631914: Intelligent Needle Tip Tracking Using Ultrasound Imaging for Infraclavicular Brachial Plexus Blocks
Official title: Intelligent Needle Tip Tracking Using Ultrasound Imaging for Infraclavicular Brachial Plexus Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
name: B. Braun Melsungen AG
First posted: 2018-08-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance time
timeFrame: During peripheral nerve block procedure
Secondary outcomes:
measure: Distance travelled by needling hand
timeFrame: During peripheral nerve block procedure
measure: Distance travelled by probe hand
timeFrame: During peripheral nerve block procedure
measure: Number of intended movements (needling hand)
timeFrame: During peripheral nerve block procedure
measure: Number of intended movements (probe hand)
timeFrame: During peripheral nerve block procedure
measure: Block success
timeFrame: 30 minutes after peripheral nerve block procedure
measure: Block onset time
timeFrame: Within 60 minutes after peripheral nerve block procedure
measure: Block duration
timeFrame: Within 240 minutes after peripheral nerve block procedure
measure: Quantified discomfort during block performance
timeFrame: Immediately after peripheral nerve block procedure
measure: Confidence in block success
timeFrame: Immediately after peripheral nerve block procedure
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
citation: Kasine T, Romundstad L, Rosseland LA, Fagerland MW, Kessler P, Omenas IN, Holmberg A, Sauter AR. Ultrasonographic needle tip tracking for in-plane infraclavicular brachialis plexus blocks: a randomized controlled volunteer study. Reg Anesth Pain Med. 2020 Aug;45(8):634-639. doi: 10.1136/rapm-2020-101349. Epub 2020 Jun 14.