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NCT Number: NCT02533557

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

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.

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Key information

Conditions

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

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

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".

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
  • 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

Treatment and study plan

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.

Other names: D Plus B.Braun

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.

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 at 5-minute intervals (from date of randomization until the date of first documented progression)

    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.

Secondary outcomes

  1. the onset time

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

    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.

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study 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

Acronym: US-SCBPB

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 27, 2015
Registry last updated
May 20, 2016

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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