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Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks

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ClinicalTrials.gov Identifier: NCT03667898
Recruitment Status : Completed
First Posted : September 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
Philips Medical Systems
B. Braun Melsungen AG
Information provided by (Responsible Party):
Axel Rudolf Sauter, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Nerve Block Procedure: Lumbar plexus block using NTT Procedure: Lumbar plexus block without NTT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Active needle tip tracking
A needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
Procedure: 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.
Procedure: Lumbar plexus block without NTT
An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.




Primary Outcome Measures :
  1. Performance time [ Time Frame: During peripheral nerve block procedure ]
    Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection


Secondary Outcome Measures :
  1. Distance travelled by needling hand [ Time Frame: During peripheral nerve block procedure ]
    Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection

  2. Distance travelled by probe hand [ Time Frame: During peripheral nerve block procedure ]
    Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection

  3. Number of intended movements (needling hand) [ Time Frame: During peripheral nerve block procedure ]
    Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection

  4. Number of intended movements (probe hand) [ Time Frame: During peripheral nerve block procedure ]
    Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection

  5. Block success [ Time Frame: 30 minutes after peripheral nerve block procedure ]
    A sensory block is defined as successful when there is analgesia (no sensation for touch) or anaesthesia (no sensation at all) involving all five nerves distal to the elbow

  6. Block onset time [ Time Frame: Within 30 minutes after peripheral nerve block procedure ]
    Block onset time is defined as the time between the end of LA injection and development of a successful sensory block

  7. Block duration [ Time Frame: Within 240 minutes after peripheral nerve block procedure ]
    Block duration is the time from the end of LA injection until at least one of the nerves involved in the sensory block has recovered

  8. Quantified discomfort during block performance [ Time Frame: Immediately after peripheral nerve block procedure ]
    The participants are asked about discomfort during the block procedure using a numeric rating scale (scale range 0 - 10; 0 = no discomfort; 10 = worst discomfort imaginable)

  9. Confidence in block success [ Time Frame: Immediately after peripheral nerve block procedure ]
    The anaesthetist is asked if he expects the block to be successful using a numeric rating scale (scale range 0 - 10; 0 = block success unlikely; 10 = block success very likely)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667898


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Philips Medical Systems
B. Braun Melsungen AG

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Responsible Party: Axel Rudolf Sauter, Pricipal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03667898     History of Changes
Other Study ID Numbers: 2018/1100
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No