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Comparison 1 Plane-2 Injection and 2 Plane-2 Injection Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCBPB)

G

Gachon University Gil Medical Center

Status

Completed

Conditions

Radius Fractures

Treatments

Drug: lidocaine mixed with epinephrine
Device: stimuplex insulated needle

Study type

Interventional

Funder types

Other

Identifiers

NCT02533557
GBIRB2015-45

Details and patient eligibility

About

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.

Full 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".

Enrollment

70 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

70 participants in 2 patient groups

2P2I group
Experimental group
Description:
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.
Treatment:
Drug: lidocaine mixed with epinephrine
Device: stimuplex insulated needle
1P2I group
Active Comparator group
Description:
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.
Treatment:
Drug: lidocaine mixed with epinephrine
Device: stimuplex insulated needle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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