Intelligent Needle Tip Tracking Using Ultrasound Imaging for Lumbar Plexus Blocks
- Conditions
- Nerve Block
- Interventions
- Procedure: Lumbar plexus block using NTTProcedure: Lumbar plexus block without NTT
- Registration Number
- NCT03667898
- Lead Sponsor
- Oslo University Hospital
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- American Society of Anesthesiologists (ASA) physical status 1 or 2
- Volunteers that have given informed written consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active needle tip tracking Lumbar plexus block using NTT A needle tip tracking system is used when performing an ultrasound guided lumbar plexus block. Inactive needle tip tracking Lumbar plexus block without NTT No needle tip tracking system is used when performing an ultrasound guided lumbar plexus block.
- Primary Outcome Measures
Name Time Method Performance time 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 Outcome Measures
Name Time Method Confidence in block success 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)
Number of intended movements (needling hand) 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 During peripheral nerve block procedure Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection
Block onset time 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 success 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
Quantified discomfort during block performance 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)
Distance travelled by needling hand 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) During peripheral nerve block procedure Measured by motion analysis from insertion of the block needle (skin puncture) until finishing LA injection
Block duration 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
Trial Locations
- Locations (1)
Oslo University Hospital
🇳🇴Oslo, Norway