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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00992810
First received: October 8, 2009
Last updated: January 22, 2010
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medial vs. Lateral Approach to Ultrasound-Guided Supraclavicular Block: A Prospective Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Richard Brull, University Health Network
ClinicalTrials.gov Identifier: NCT00992810     History of Changes
Other Study ID Numbers: 09-0451-B
Study First Received: October 8, 2009
Last Updated: January 22, 2010
Health Authority: Canada: Canadian REB

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

ClinicalTrials.gov processed this record on June 17, 2013