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

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ClinicalTrials.gov Identifier: NCT03631914
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : October 9, 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 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.

Condition or disease Intervention/treatment Phase
Nerve Block Procedure: Infraclavicular brachial plexus block Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 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 Infraclavicular Brachial Plexus Blocks
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 28, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Active needle tip tracking
A needle tip tracking system is used when performing an ultrasound guided infraclavicular brachial plexus block.
Procedure: Infraclavicular brachial plexus block
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.
Procedure: Infraclavicular brachial plexus block
An infraclavicular brachial plexus block is performed using ultrasound guidance.




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 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 60 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)



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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:

  • 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): NCT03631914


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

Responsible Party: Axel Rudolf Sauter, Pricipal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03631914     History of Changes
Other Study ID Numbers: 2018/1098
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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