Randomized Controlled Trial of Ultrasound Guided Needle Placement Versus Nerve Stimulation for Coracoid Infraclavicular Brachial Plexus Block

December 17, 2008 updated by: University Health Network, Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network, Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

The Physicians' Services Incorporated Foundation
Canadian Anesthesiologists' Society

Investigators

  • Principal Investigator: Colin JL McCartney, MBChB FRCA FCARCSI FRCPC, University Health Network, Toronto Western Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 12, 2006

First Submitted That Met QC Criteria

May 12, 2006

First Posted (ESTIMATE)

May 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

April 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • 03-0126-AE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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