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

Not Applicable

Completed

• Conditions: Brachial Plexus Block
• Interventions: Procedure: Posterior approach

• Registration Number: NCT02312453
• Lead Sponsor: University of Malaya

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2014-11-28
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-06
• Last Update Submitted: 2014-12-06
• Study First Posted: 2014-12-09
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Posterior approach	Posterior approach	All patients were given a single shot ultrasound-guided posterior parasagittal in-plane approach infraclavicular brachial plexus block under aseptic technique. The blocks were performed using a 21G, 100 mm insulated short bevel needle (Stimuplex A, B Braun, Melsungen, Germany) without nerve stimulation. A 25-ml local anaesthetic admixture \[Lignocaine 2% (100mg) plus Ropivacaine 0.75% (150mg)\] was administered. We used an ultrasound machine (Sonosite M-Turbo; Sonosite®, Bothell, WA, USA) with HFL38x/ 13-6 MHz linear transducer probe.

Primary Outcome Measures

Name	Time	Method
Success rate (ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon)	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 Outcome Measures

Name	Time	Method
Performance parameters	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).
Safety aspects and potential complications as measured by incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity	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.
adequacy of block for tourniquet application	participants will be followed up throughout operation	The incidence of tourniquet pain