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

NCT02533557 | Completed

• 1 other identifier: GBIRB2015-45
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Radius Fractures

Keywords

brachial plexus block; nerve stimulator; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• the onset time

  check 30 minutes after performing the block at 5-minute intervals(from date of randomization until the date of first documented progression)

Study Arms (2)

2P2I group

EXPERIMENTAL

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

1P2I group

ACTIVE COMPARATOR

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 with a direction of upward at the same puncture site and penetrated the nerve sheath. If hand muscle twitching is observed at 0.3 mA, LA 15 mL is injected.

Device: stimuplex insulated needle; Drug: lidocaine mixed with epinephrine

Interventions

stimuplex insulated needle DEVICE

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.

Also known as: D Plus B.Braun

1P2I group; 2P2I group

lidocaine mixed with epinephrine DRUG

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.

Also known as: 1.5% lidocaine mixed with 1:200,000 epinephrine

1P2I group; 2P2I group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients anticipating surgery of the wrist or hand
• age: 18 to 80 years
• American Society of Anesthesiologists physical status (ASA): I or II

You may not qualify if:

• 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

Sponsors & Collaborators

• Gachon University Gil Medical Center: lead

Study Sites (1)

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

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

Location

Related Publications (1)

• Techasuk W, Gonzalez 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.

  PMID: 24842181 BACKGROUND

MeSH Terms

Conditions

Radius Fractures

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Forearm Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Mi Geum Lee, MD, PhD

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: August 27, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)