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OpenTrials
Completed

NCT Number: NCT03667898

Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks

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.

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Key information

Conditions

Nerve Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar plexus block using NTT

Procedure

An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.

Lumbar plexus block without NTT

Procedure

An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • B. Braun Melsungen AG
  • Philips Medical Systems

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2018
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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