Nerve Block
Conditions
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.
Interventions
An infraclavicular brachial plexus block is performed using ultrasound guidance.
Sponsors
Philips Medical Systems
B. Braun Melsungen AG
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance time | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| Block onset time | 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 |
Countries
Norway
Outcome results
None listed