Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks

Nerve Block Clinical Trial

Official title:

Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667898
• Other study ID #: 2018/1100
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 30, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block

Intervention

Procedure:
• Lumbar plexus block using NTT
An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.
• Lumbar plexus block without NTT
An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	B. Braun Melsungen AG, Philips Medical Systems

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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