ClinicalTrials.Veeva

Menu

Comparison 1 Plane-1 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB)

G

Gachon University Gil Medical Center

Status

Completed

Conditions

Radius Fractures

Treatments

Device: Stimuplex insulated needle
Drug: lidocaine mixed with epinephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT02505633
GBIRB2015-44

Details and patient eligibility

About

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.

Full description

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).

Enrollment

36 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • all patients anticipating surgery of the wrist or hand with aged 18 to 80 years and an American Society of Anesthesiologists physical status (ASA) of I or II.

Exclusion criteria

  • patients with preexisting neuropathy in the operated limb, ASA greater than III, coagulation disorders, known allergy to local anesthetics, local infection at the puncture site, chronic obstructive pulmonary disease or respiratory failure, pregnancy, breast-feeding and prior surgery in the supraclavicular region, BMI ≥ 35 kg/㎡, uncooperative patients and patients' refusal. an ultrasound view of the perfect circular neural cluster.

Trial design

36 participants in 2 patient groups

2P2I group
Experimental group
Description:
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.
Treatment:
Drug: lidocaine mixed with epinephrine
Device: Stimuplex insulated needle
1P1I group
Active Comparator group
Description:
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.
Treatment:
Drug: lidocaine mixed with epinephrine
Device: Stimuplex insulated needle

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems