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.

Study Overview

• Status: Completed
• Conditions: Nerve Block
• Intervention / Treatment: Procedure: Lumbar plexus block using NTT; Procedure: Lumbar plexus block without NTT

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance time	Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing local anaesthetic (LA) injection	During peripheral nerve block procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance travelled by needling hand	Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection	During peripheral nerve block procedure
Distance travelled by probe hand	Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection	During peripheral nerve block procedure
Number of intended movements (needling hand)	Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection	During peripheral nerve block procedure
Number of intended movements (probe hand)	Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection	During peripheral nerve block procedure
Block success	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	30 minutes after peripheral nerve block procedure
Block onset time	Block onset time is defined as the time between the end of LA injection and development of a successful sensory block	Within 30 minutes after peripheral nerve block procedure
Block duration	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	Within 240 minutes after peripheral nerve block procedure
Quantified discomfort during block performance	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)	Immediately after peripheral nerve block procedure
Confidence in block success	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)	Immediately after peripheral nerve block procedure

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: B. Braun Melsungen AG; Philips Medical Systems

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2018
• Primary Completion (ACTUAL): October 26, 2018
• Study Completion (ACTUAL): November 30, 2018

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (ACTUAL): September 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2018/1100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No