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Distance for Interscalene Block

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01568463
Collaborator
(none)
25
Enrollment
1
Location
25.8
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients experience significant postoperative pain following shoulder surgery, Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that include significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge.The process of nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound. These facts raised concerns and several authors stated that maybe the anesthesiologists should be more careful, keep a safe distance from the nerve, and inject the local anesthetics into fascial planes containing the nerve and not attempt to place the needle in close proximity to the nerve. This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    What is the Maximal Effective Distance for Interscalene Block?
    Actual Study Start Date :
    Feb 1, 2012
    Actual Primary Completion Date :
    Jan 24, 2013
    Actual Study Completion Date :
    Mar 26, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Success of the inter-scalene block at 20 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve [20 mins]

    Secondary Outcome Measures

    1. The onset time of sensory and motor block [the block success will be assessed for each patient every 5 min for 20 mins in the block room beginning when the needle exits the skin]

    2. The proportion of inadequate and failed blocks. [the block success will be assessed for each patient every 5 min for 20 mins in the block room beginning when the needle exits the skin]

    3. The duration of block, defined as the time from the completion of block performance to the time of the request for the first postoperative analgesic. [during the first 24 hours post operative]

    4. The amount of pain and level of satisfaction, [every 30 minutes starting at post anesthesia care unit admission till 120 minutes]

    5. The presence of a Claude-Bernard-Horner Syndrome [up to 24 hours post operative]

    6. The presence of hoarseness. [up to 24 hours post operative]

    7. The presence of other complications such as hematoma, infection, pneumothorax. [up to 24 hours post operative and 7 days post op]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA physical status I-III

    • 18-85 years of age, inclusive

    • surgery less than 3 hours

    Exclusion Criteria:

    • contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)

    • existing neurological deficit in the area to be blocked

    • pregnancy

    • history of neck surgery or radiotherapy

    • severe respiratory disease

    • inability to understand the informed consent and demands of the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Toronto Western Hospital Toronto Ontario Canada M5T 2S8

    Sponsors and Collaborators

    • University Health Network, Toronto

    Investigators

    • Principal Investigator: Richard Brull, MD, FRCPC, University of Toronto

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Health Network, Toronto
    ClinicalTrials.gov Identifier:
    NCT01568463
    Other Study ID Numbers:
    • 11-0806-A
    First Posted:
    Apr 2, 2012
    Last Update Posted:
    Jan 10, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by University Health Network, Toronto
    Inter-scalene Block
    Regional Anesthesia
    shoulder surgeries

    Study Results

    No Results Posted as of Jan 10, 2018