NCT02462408

Brief Summary

The lateral parasagittal in-plane is the current conventional approach in ultrasound-guided infraclavicular brachial plexus block. However this technique is less popular because brachial plexus at the infraclavicular level runs deeper compared to its course proximally, often give rise to impaired needle visualisation due to its steep angle of needle trajectory to the ultrasound beam. A new posterior parasagittal in-plane approach was introduced to improve needle visibility. This approach proved feasible from our case series hence the investigators would like to compare it with the conventional method in this study

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 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

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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
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

April 1, 2015

Last Update Submit

June 1, 2015

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 the operation duration; as stated each operation has variable duration of operation time, average operation time 2 to 4 hours

Secondary Outcomes (3)

  • Performance parameters

    participants will be followed up throughout the procedure (performing the blocks), average time for block perfomances 30 minutes

  • Safety aspects and potential complications; we measured by any incidence of paraesthesia, vascular puncture, Horner's syndrome, dyspnoea and symptoms suggestive of LA toxicity

    Participants would be followed up throughout procedure (average duration 30 minutes), during operation (average duration 2 to 4 hours) and 1 week after the operation (via phone call)

  • adequacy of block for tourniquet application

    participants would be followed up throughout the operation duration whether they complained of pain at torniquet site during the operation duration; average duration of operation 2 - 4 hours

Study Arms (2)

Posterior approach

EXPERIMENTAL

The main difference between this block approach and the conventional infraclavicular approach is the site and angle of needle insertion. Otherwise, the end point of local anaesthetic injection remained the same for both approaches.

Procedure: Posterior approach

Conventional approach

ACTIVE COMPARATOR

The main difference between this block approach and the conventional infraclavicular approach is the site and angle of needle insertion. Otherwise, the end point of local anaesthetic injection remained the same for both approaches.

Procedure: Conventional approach

Interventions

The needle insertion point was over the trapezius muscle sufficiently posterior to allow the needle to pass between the clavicle and the scapula in the direction of the axillary artery. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.

Posterior approach

The needle insertion point would be at the cephalad (lateral) aspect of the ultrasound probe, beneath the clavicle and medial to the coracoid process. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.

Conventional approach

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I - III
  • Body Mass Index (BMI) between 20 and 35 kg/m2
  • Surgery of the forearm, wrist, or hand

You may not qualify if:

  • Inability to give consent to the study
  • Pre-existing neuropathy
  • Infection at the site of puncture, skin ulcer
  • Coagulopathy
  • Contralateral phrenic nerve paralysis, contralateral recurrent laryngeal nerve paralysis or pneumothorax
  • Allergy to amides local anaesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Chin KJ, Perlas A, Chan VW, Brull R. Needle visualization in ultrasound-guided regional anesthesia: challenges and solutions. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):532-44. doi: 10.1016/j.rapm.2008.06.002.

    PMID: 19258968BACKGROUND
  • Hebbard P, Royse C. Ultrasound guided posterior approach to the infraclavicular brachial plexus. Anaesthesia. 2007 May;62(5):539. doi: 10.1111/j.1365-2044.2007.05066.x. No abstract available.

    PMID: 17448088BACKGROUND
  • Tran DQ, Charghi R, Finlayson RJ. The "double bubble" sign for successful infraclavicular brachial plexus blockade. Anesth Analg. 2006 Oct;103(4):1048-9. doi: 10.1213/01.ane.0000239077.49794.a5. No abstract available.

    PMID: 17000840BACKGROUND
  • Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.

    PMID: 20048654BACKGROUND

Study Officials

  • Beh Zhi Yuen, MD, M.Anaes

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anaesthetist

Study Record Dates

First Submitted

April 1, 2015

First Posted

June 4, 2015

Study Start

November 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

June 4, 2015

Record last verified: 2015-06