NCT00326261

Brief Summary

Nerve blocks for arm and hand surgery provide many advantages for patients including excellent pain control and reduction in general anesthesia-related adverse effects. Infraclavicular block is possibly the best method for performing regional anesthesia of the arm because of the consistent anesthesia of the whole arm and low incidence of serious adverse effects. Normally the anesthetist uses nerve stimulation to identify nerves supplying the forearm and hand. Recent research has indicated that to improve success from 60% to 79% two types of muscle stimulation must be sought before injection of local anesthetic. This can be time consuming, requires a significant learning process, increases complications and leaves 21% of patients with inadequate anesthesia requiring supplementation or general anesthesia. More recently practitioners have been using ultrasound imaging to direct the needle and watch local anesthetic spread around the nerves. Preliminary reports have documented that this technique is associated with much greater success than the nerve stimulation method. However a good quality study comparing the dual-endpoint infraclavicular technique with an ultrasound-guided technique has not been performed. This randomized study aims to rectify this deficiency by determining if ultrasound-guided infraclavicular block has a significantly greater success than the current standard, dual end-endpoint nerve stimulation technique.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
Last Updated

December 18, 2008

Status Verified

April 1, 2006

First QC Date

May 12, 2006

Last Update Submit

December 17, 2008

Conditions

Interventions

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing elective upper limb surgery at or below the elbow.
  • Patients aged \> 18 and \< 80 years.
  • ASA I-III.
  • BMI \< 35.

You may not qualify if:

  • Inability to read, write or speak English. (This is necessary because subjects will have to follow detailed instructions to allow testing of motor and sensory function. it is not feasible to have an interpreter present in the block room during performance of these procedures).
  • Contraindication to brachial plexus block.
  • Existing neurological deficit in the area to be blocked.
  • Known loco-regional malignancy or infection.
  • Coagulopathy.
  • Allergy to local anesthetic agents.
  • Chest or shoulder deformities.
  • Severe respiratory disease.
  • Healed but dislocated clavicle fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

  • Brull R, Lupu M, Perlas A, Chan VW, McCartney CJ. Compared with dual nerve stimulation, ultrasound guidance shortens the time for infraclavicular block performance. Can J Anaesth. 2009 Nov;56(11):812-8. doi: 10.1007/s12630-009-9170-2.

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Colin JL McCartney, MBChB FRCA FCARCSI FRCPC

    University Health Network, Toronto Western Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 16, 2006

Last Updated

December 18, 2008

Record last verified: 2006-04

Locations