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NCT Number: NCT02312453

Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block

Abstract

Introduction: The brachial plexus at the infraclavicular level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach. A new posterior parasagittal in-plane ultrasound-guided infraclavicular approach was introduced to improve needle visibility. However no further follow up study was done.

Methods: We performed a case series and a cadaveric dissection to assess its feasibility in a single centre, University of Malaya Medical Centre, Kuala Lumpur, Malaysia from November 2012 to October 2013. After obtaining approval from the Medical Ethics Committee, University Malaya Medical Centre, 18 patients undergoing upper limb surgery were prospectively recruited. A cadaveric dissection was also performed. The endpoints of this study were the success rate, performance time, total anaesthesia related time, quality of anaesthesia and any incidence of complications.

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Key information

Conditions

Brachial Plexus Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Introduction Our study focus on the ultrasound guided infraclavicular brachial plexus block, which is a cord-level block of the brachial plexus for surgical procedures below mid-humerus. The brachial plexus at this level runs deeper compared to its course proximally, giving rise to impaired needle visualisation due to the steep angle of needle insertion with the current ultrasound-guided approach (lateral para-sagittal in-plane technique).1

A new ultrasound-guided posterior approach parasagittal in-plane infraclavicular block was introduced to improve needle visibility.2 However no further follow up study was done.

Therefore, we performed a case series of 18 patients with a cadaveric dissection, to assess the feasibility of this approach.

Methods After obtaining ethics committee approval from the Medical Ethics Committee, University Malaya Medical Center, Kuala Lumpur, Malaysia (Chairperson Professor Dr. Looi Lai Meng; IRB reference no. 949.14 dated 17 October 2012, amendment no.1038.76 dated 19 December 2013) and written informed consent, 18 patients undergoing surgery of the elbow, forearm, wrist, or hand were prospectively recruited based on the criteria below.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient's age between 18 and 80 years old,
  • American Society of Anesthesiologists (ASA) physical status I - III,
  • body mass index (BMI) between 20 and 35 kg/m2 and
  • planned for surgery of the forearm, wrist, or hand.

Exclusion criteria

  • patient's inability to give consent to the study,
  • pre-existing neuropathy,
  • infection at the site of puncture,
  • coagulopathy, and
  • allergy to amides local anaesthetics.

Treatment and study plan

Posterior Approach

Procedure

We adopted the technique as described by Hebbard et al.

Other names: posterior approach parasagittal in-plane

Primary outcomes

  1. Success rate (ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon)

    Time frame: participants will be followed up throughout operation duration

    Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon

    The adequacy of block was determined during assessment of motor and sensory blockade at predetermined intervals, every 5 minutes until 30 minutes; Please refer to the study detailed description.

Secondary outcomes

  1. Performance parameters

    Time frame: participants will be followed up throughout the procedure

    Imaging time (defined as the time interval between contact of the ultrasound probe with the patient and the acquisition of a satisfactory sonoanatomy - a complete round short-axis view of the axillary artery) Needling time (defined as the time interval between the start of the needle insertion and the end of local anaesthetic injection through the needle) Performance time (defined as the sum of imaging and needling times).

  2. Safety aspects and potential complications as measured by incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity

    Time frame: participants will be followed up throughout procedure, during operation and 1 week after the operation (via phone call)

    The incidence of paraesthesia and vascular puncture was recorded if any. Horner's syndrome, dyspnoea and symptoms suggestive of local anaesthetic toxicity were routinely checked.

  3. adequacy of block for tourniquet application

    Time frame: participants will be followed up throughout operation

    The incidence of tourniquet pain

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

Posterior Parasagittal In-Plane Ultrasound-Guided Infraclavicular Brachial Plexus Block - A Case Series

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2014
Registry last updated
Dec 9, 2014

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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