NCT02312453

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

November 28, 2014

Last Update Submit

December 6, 2014

Conditions

Outcome Measures

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)

    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.

    participants will be followed up throughout operation duration

Secondary Outcomes (3)

  • Performance parameters

    participants will be followed up throughout the procedure

  • 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)

  • adequacy of block for tourniquet application

    participants will be followed up throughout operation

Study Arms (1)

Posterior approach

EXPERIMENTAL

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.

Procedure: Posterior approach

Interventions

We adopted the technique as described by Hebbard et al.

Also known as: posterior approach parasagittal in-plane
Posterior approach

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • References 1. Chin KJ, Perlas A, Chan VW, et al. Needle visualization in ultrasound guided regional anaesthesia: challenges and solutions. Reg Anesth Pain Med 2008; 33:532-544 2. Hebbard P and Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia 2007; 62: 539 3. Levesque S, Dion N, Desgagne MC. Endpoint for successful, ultrasound-guided infraclavicular brachial plexus block. Can J Anaesth 2008; 55:308. 4. Tran DQH, Charghi R, Finlayson RJ. The 'Double Bubble' Sign for Successful Infraclavicular Brachial Plexus Blockade. Anesth Analg 2006; 103:1048-1049 5. Tran DQH, Bertini P, Zaouter C, et al. A Prospective, Randomized Comparison Between Single- and Double-Injection Ultrasound-Guided Infraclavicular Brachial Plexus Block. Reg Anesth Pain Med 2010; 35:16-21 6. Tran DQH, Munoz L, Zaouter C, et al. A prospective, randomized comparison between single- and double-injection ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med 2009; 34:420-424. 7. Tran DQH, Russo G, Munoz L, et al. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular and axillary brachial plexus blocks. Reg Anesth Pain Med 2009; 34:366-371

    BACKGROUND
  • Beh ZY, Hasan MS, Lai HY, Kassim NM, Md Zin SR, Chin KF. Posterior parasagittal in-plane ultrasound-guided infraclavicular brachial plexus block-a case series. BMC Anesthesiol. 2015 Jul 21;15:105. doi: 10.1186/s12871-015-0090-0.

Study Officials

  • Beh Zhi Yuen, MD, M.Anaes

    Department of Anaesthesiology, Faculty of Medicine, Univeristy of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 9, 2014

Study Start

November 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 9, 2014

Record last verified: 2014-12