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Distance for Interscalene Block

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ClinicalTrials.gov Identifier: NCT01568463
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):

March 6, 2012
April 2, 2012
January 10, 2018
February 2012
January 24, 2013   (Final data collection date for primary outcome measure)
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 [ Time Frame: 20 mins ]
Same as current
Complete list of historical versions of study NCT01568463 on ClinicalTrials.gov Archive Site
  • The onset time of sensory and motor block [ Time Frame: 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 ]
  • The proportion of inadequate and failed blocks. [ Time Frame: 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 ]
  • 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. [ Time Frame: during the first 24 hours post operative ]
  • The amount of pain and level of satisfaction, [ Time Frame: every 30 minutes starting at post anesthesia care unit admission till 120 minutes ]
  • The presence of a Claude-Bernard-Horner Syndrome [ Time Frame: up to 24 hours post operative ]
  • The presence of hoarseness. [ Time Frame: up to 24 hours post operative ]
  • The presence of other complications such as hematoma, infection, pneumothorax. [ Time Frame: up to 24 hours post operative and 7 days post op ]
Same as current
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Distance for Interscalene Block
What is the Maximal Effective Distance for Interscalene Block?
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.
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Observational
Observational Model: Other
Time Perspective: Prospective
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Non-Probability Sample
Patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery)
  • Regional Anesthesia
  • Inter Scalene Block
  • Post Operative Analgesia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 26, 2014
January 24, 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01568463
11-0806-A
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University Health Network, Toronto
University Health Network, Toronto
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Principal Investigator: Richard Brull, MD, FRCPC University of Toronto
University Health Network, Toronto
January 2018