- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00992810
Medial Versus Lateral Approach in Ultrasound (US)-Guided Supraclavicular Block
November 30, 2017 updated by: University Health Network, Toronto
Medial vs. Lateral Approach to Ultrasound-Guided Supraclavicular Block: A Prospective Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
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
-
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Toronto Western Hospital
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-
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:
- 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.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lateral-to-Medial Approach
Needle approach to the brachial plexus nerves will be made using a lateral-to-medial direction.
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Approach of the needle to administer the brachial plexus nerve block will be done in a lateral-to-medial direction.
|
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Experimental: Medial-to-Lateral Approach
Needle approach to the brachial plexus nerves will be made using a lateral-to-medial direction.
|
Approach of the needle to administer the brachial plexus nerve block will be done in a medial-to-lateral direction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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1 hour prior to surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard Brull, MD, University Health Network, Toronto
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 Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
October 8, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (Estimate)
October 9, 2009
Study Record Updates
Last Update Posted (Actual)
December 4, 2017
Last Update Submitted That Met QC Criteria
November 30, 2017
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09-0451-B
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.