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Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by University Health Network, Toronto.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992810
First Posted: October 9, 2009
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Health Network, Toronto
  Purpose
The ultrasound guided supraclavicular block is a peripheral nerve block which is considered safe, has a fast onset, is dense and provides complete block of the nerves supplying the hand, forearm and arm. However retrospective studies done at Toronto Western Hospital have highlighted the fact that most commonly the ulnar nerve fibres (responsible for sensations in the ring finger, little finger and the corresponding part of hand), sometimes escape this block and need additional supplementary block at a distal peripheral nerve site. It is a confusing fact since all nerve fibres are compactly arranged in a sheath at the supraclavicular level. The local anaesthetic agent at this level should be equally distributed among all nerve fibres. The purpose of this study is to compare two different approaches (medial and lateral) adopted by our clinicians to perform this block and to test the effectiveness of each approach for successful ulnar nerve fibre blockade.

Condition Intervention
Hand or Arm Surgery Procedure: Lateral-to-Medial Approach Procedure: Media-to-Lateral Approach

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medial vs. Lateral Approach to Ultrasound-Guided Supraclavicular Block: A Prospective Randomized Controlled Trial

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Successful block of the Ulnar nerve (C8,T1) fibres. Sensory block with a score of '1' at 30 minutes (loss of sensation to pin prick) is considered successful. [ Time Frame: 1 hour prior to surgery ]

Estimated Enrollment: 78
Study Start Date: August 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lateral-to-Medial Approach
Needle approach to the brachial plexus nerves will be made using a lateral-to-medial direction.
Procedure: Lateral-to-Medial Approach
Approach of the needle to administer the brachial plexus nerve block will be done in a lateral-to-medial direction.
Experimental: Medial-to-Lateral Approach
Needle approach to the brachial plexus nerves will be made using a lateral-to-medial direction.
Procedure: Media-to-Lateral Approach
Approach of the needle to administer the brachial plexus nerve block will be done in a medial-to-lateral direction.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients presenting for upper limb surgery, excluding shoulder surgery
  • Age 18-80 yrs
  • BMI < 35
  • ASA I - III
  • Consent for the study

Exclusion Criteria:

  • Pre-existing sensory or motor neurodeficit.
  • Sensitivity to local anaesthetic agents.
  • Patients on anticoagulants or antiplatelet medications (Minidose Aspirin is acceptable) with abnormal coagulation profile.
  • Compromised pulmonary reserve due to COPD, Kypho-scoliosis or Restricted lung disease.
  • Infection or any obvious pathology at the site of block performance
  • History of drug abuse.
  • Psychiatric disease or any condition that precludes an informed consent.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00992810


Contacts
Contact: Alex Kerr, BSc 416 603-5118 alex.kerr@uhn.on.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Alex Kerr, BSc    416 603-5118    alex.kerr@uhn.on.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Richard Brull, MD University Health Network, Toronto
  More Information

Responsible Party: Dr. Richard Brull, University Health Network
ClinicalTrials.gov Identifier: NCT00992810     History of Changes
Other Study ID Numbers: 09-0451-B
First Submitted: October 8, 2009
First Posted: October 9, 2009
Last Update Posted: January 26, 2010
Last Verified: January 2010

Keywords provided by University Health Network, Toronto:
upper limb
hand
arm
surgery
supraclavicular nerve block
brachial plexus nerve block
ultrasound-guided regional anesthesia