An interventional study of Stimuplex insulated needle and lidocaine mixed with epinephrine in Radius Fractures, sponsored by Gachon University Gil Medical Center. Completed at 1 site in South Korea. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-10.
Sponsored by Gachon University Gil Medical Center · Not applicable and Interventional
Ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) has been a generalized regional anesthesia in upper extremity surgery. It is performed just above the clavicle, in which the neural cluster formed by the trunks or divisions of the brachial plexus is situated superolateral to the subclavian artery (SA).
In many approaches, corner pocket approach [deposit local anesthetic (LA) at the intersection of the SA, neural cluster, and the first rib] and cluster approach (direct deposit LA into the neural cluster after penetration of the sheath of brachial plexus) has been well known methods. And single or multiple injection techniques has been used with the above approaches.
In clinical practices, the investigators observed that the neural cluster was shown differently every person on the ultrasound image. Some neural cluster is shown as a typical round cluster of grapes lateral to the SA, in which, any approaches of US-SCBPB can be possible and good success rates are anticipated. But in many cases, neural cluster was shown in part lateral or superolateral to the SA like slightly-hated SA on the ultrasound image, and it passes posterior to the SA when the probe follows the path of the neural cluster along the SA. In that case, corner pocket approach is hard to apply due to the position of the neural cluster far away from the first rib, cluster approach increases chance of lopsided spreading of the LA, and multiple injection is also hard to apply due to narrow-shaped neural cluster. Therefore, we hypothesized that double injection in different plane (we call this new approach as a 2 plane-2 injection approach) would achieve an effect of a "tridimensionally administered LA", which is presented like shortening the onset time or increasing rate of all four nerves block compared with the existing cluster approach (the investigators call this as an 1 plane- 1 injection approach in this study).
274 studies on the registry are indexed under Radius Fractures; 35 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 219 interventional studies indexed under Radius Fractures.
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subcutaneous injection is done widely. A nerve stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12; B. Braun, Melsungen, Germany) is advanced via an ultrasound in-plane approach. After the needle is penetrated the nerve sheath with a direction of downward, the nerve stimulator is then turned on. If hand muscle twitching is observed even at 0.3 mA, LA 15 mL (lidocaine mixed with epinephrine) is injected. After that, the stimulating needle is re-advanced at the behind site of the initial puncture site. And the needle is penetrated the nerve sheath with a direction of upward, and then the same process is performed and LA 15 mL is injected.
Device: Stimuplex insulated needle · Drug: lidocaine mixed with epinephrine
After subcutaneous injection of 1 mL of 2% lidocaine, a nerve stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12; B. Braun, Melsungen, Germany) is advanced via an ultrasound in-plane approach from lateral to medial direction. After the needle is penetrated the nerve sheath, the nerve stimulator is then turned on, and the stimulation current starts at 0.5mA. If hand muscle twitching is observed even at 0.3 mA, local anesthetics 30 mL (lidocaine mixed with epinephrine) is injected.
Device: Stimuplex insulated needle · Drug: lidocaine mixed with epinephrine
2P2I group: nerve stimulating needle is advanced twice and LA is injected 15 mL at a time. 1P1I group: nerve stimulating needle is advanced once and LA is injected 30 mL.
Also known as: (D Plus B.Braun)
2P2I group and 1P1I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time). 1P1I group is injected LA 30 mL at once.
Also known as: 1.5% lidocaine mixed with 1:200,000 epinephrine
rate of complete sensory blockade of all 4 nerves.
If the sensory on the site under the control of all 4 (median, radial, ulnar, musculocutaneous) nerves is checked as 0 (just feeling of touch or none ) separately, it is considered as a complete sensory block. the investigators compare the rate of complete sensory block with 2P2I group and 1P1I group.
Time frame: check 30 minutes after performing the block
the onset time
The investigators compare the onset time (time required to obtain of a sensory block at the surgical incision site) with 2P2I group and 1P1I group.
Time frame: check 30 minutes after performing the block
The record gives a start of Jul 2015, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Gachon University Gil Medical Center