Comparison 1 Plane-2 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-2 Injection 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: NCT02533557
• Other study ID #: GBIRB2015-45
• Status: Completed
• Phase: N/A
• First received: August 21, 2015
• Last updated: May 18, 2016
• Start date: August 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• 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

The supraclavicular block can provide effective surgical anesthesia of the forearm and hand. There have been many different approaches to ultrasound-guided supraclavicular brachial plexus block (US-SCBPB) according to the needle injection site (e.g. corner pocket approach, cluster approach) or number of needling (single or double injection). Numerous studies demonstrates good results (e.g. faster onset time) when using double injections rather than single injection. But double injection does not guarantee complete sensory block because ulnar nerve tends to be spared by its anatomical location.

Description:

The investigators hypothesized that double injection in different plane (we call this new approach as a 2 plane-2 injection approach;2P2I) would overcome the weakness of the existing double injection in same plane (we call this approach as a 1 plane-2 injection approach;1P2I) like "ulnar nerve sparing effect", and could have a good results (e.g. shortening the onset time or increasing rate of all four nerves block). Because 2P2I can achieve an effect of a "tridimensionally administered LA", rather 1P2I only achieve an effect of a " two-dimensionally administered LA".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 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

• age: 18 to 80 years

• American Society of Anesthesiologists physical status (ASA): I or II

Exclusion Criteria:

• 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 or breast-feeding

• prior surgery in the supraclavicular region

• BMI = 35 kg/?

• uncooperative patients

• patients' refusal

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 with the up-down direction at the different puncture site and LA is injected 15 mL at a time. 1P2I group: nerve stimulating needle is advanced twice with the up-down direction at the same puncture site and LA is injected 15 mL at a time.

Drug:
• lidocaine mixed with epinephrine
2P2I group and 1P2I 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) with the up-down direction at the different puncture site. 1P2I group is injected LA at equally divided doses with the up-down direction at the same puncture site.

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 1P2I group.	check 30 minutes after performing the block at 5-minute intervals (from date of randomization until the date of first documented progression)	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 1P2I group.	check 30 minutes after performing the block at 5-minute intervals(from date of randomization until the date of first documented progression)	No