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

NCT02505633 | Completed

• 1 other identifier: GBIRB2015-44
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

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 1P1I group.

  check 30 minutes after performing the block

Secondary Outcomes (1)

• the onset time

  check 30 minutes after performing the block

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

1P1I group

ACTIVE COMPARATOR

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.

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

Interventions

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.

Also known as: (D Plus B.Braun)

1P1I group; 2P2I group

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.

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

1P1I 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 with aged 18 to 80 years and an American Society of Anesthesiologists physical status (ASA) of I or II.

You may not qualify if:

• 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.

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: July 19, 2015
• First Posted: July 22, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

KR (1)