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Completed

NCT Number: NCT02505633

Comparison 1 Plane-1 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center

Incheon, Guwol-dong, Namdong-gu, 405-760, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stimuplex insulated needle

Device

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.

Other names: (D Plus B.Braun)

lidocaine mixed with epinephrine

Drug

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.

Other names: 1.5% lidocaine mixed with 1:200,000 epinephrine

Primary outcomes

  1. rate of complete sensory blockade of all 4 nerves.

    Time frame: check 30 minutes after performing the block

    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.

Secondary outcomes

  1. the onset time

    Time frame: check 30 minutes after performing the block

    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.

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

A Randomized Comparison Between 1 Plane - 1 Injection (Cluster Approach) and 2 Plane - 2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB) in Upper Extremity Surgery

Acronym: US-SCBPB

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2015
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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