Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
NCT ID: NCT03667898
Last Updated: 2018-12-12
Study Results
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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COMPLETED
NA
27 participants
INTERVENTIONAL
2018-10-08
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Active needle tip tracking
A needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
Lumbar plexus block using NTT
An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.
Inactive needle tip tracking
No needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
Lumbar plexus block without NTT
An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.
Interventions
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Lumbar plexus block using NTT
An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.
Lumbar plexus block without NTT
An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.
Eligibility Criteria
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Inclusion Criteria
* Volunteers that have given informed written consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Philips Medical Systems
INDUSTRY
B. Braun Melsungen AG
INDUSTRY
Oslo University Hospital
OTHER
Responsible Party
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Axel Rudolf Sauter
Pricipal Investigator
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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Other Identifiers
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2018/1100
Identifier Type: -
Identifier Source: org_study_id