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| Name | Class |
|---|---|
| Philips Medical Systems | INDUSTRY |
| B. Braun Melsungen AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active needle tip tracking | Active Comparator | A needle tip tracking system is used when performing an ultrasound guided infraclavicular brachial plexus block. |
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| Inactive needle tip tracking | Other | No needle tip tracking system is used when performing an ultrasound guided infraclavicular brachial plexus block. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infraclavicular brachial plexus block | Procedure | An infraclavicular brachial plexus block is performed using ultrasound guidance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Performance time | Performance time is defined as the time from insertion of the block needle (skin puncture) until finishing LA injection | During peripheral nerve block procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32540878 | Derived | Kasine T, Romundstad L, Rosseland LA, Fagerland MW, Kessler P, Omenas IN, Holmberg A, Sauter AR. Ultrasonographic needle tip tracking for in-plane infraclavicular brachialis plexus blocks: a randomized controlled volunteer study. Reg Anesth Pain Med. 2020 Aug;45(8):634-639. doi: 10.1136/rapm-2020-101349. Epub 2020 Jun 14. |
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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 60 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 |