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

Radius Fractures Clinical Trial

— US-SCBPB  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505633
• Other study ID #: GBIRB2015-44
• Status: Completed
• Phase: N/A
• First received: July 19, 2015
• Last updated: September 8, 2015
• Start date: July 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Radius Fractures

Intervention

Device:
• Stimuplex insulated needle
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.

Drug:
• lidocaine mixed with epinephrine
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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Gachon University Gil Medical Center	Incheon	Guwol-dong, Namdong-gu

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Techasuk W, González AP, Bernucci F, Cupido T, Finlayson RJ, Tran DQ. A randomized comparison between double-injection and targeted intracluster-injection ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2014 Jun;118(6):1363-9. doi: 10.1213/ANE.0000000000000224. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	check 30 minutes after performing the block	No
Secondary	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.	check 30 minutes after performing the block	No