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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

Tracking Information
First Submitted Date  ICMJE September 7, 2018
First Posted Date  ICMJE September 12, 2018
Last Update Posted Date December 12, 2018
Actual Study Start Date  ICMJE October 8, 2018
Actual Primary Completion Date October 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03667898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
Official Title  ICMJE Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Nerve Block
Intervention  ICMJE
  • Procedure: Lumbar plexus block using NTT
    An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.
  • Procedure: Lumbar plexus block without NTT
    An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.
Study Arms  ICMJE
  • Experimental: Active needle tip tracking
    A needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
    Intervention: Procedure: Lumbar plexus block using NTT
  • Inactive needle tip tracking
    No needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
    Intervention: Procedure: Lumbar plexus block without NTT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2018)
27
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date October 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03667898
Other Study ID Numbers  ICMJE 2018/1100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axel Rudolf Sauter, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • Philips Medical Systems
  • B. Braun Melsungen AG
Investigators  ICMJE Not Provided
PRS Account Oslo University Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP