Distance for Interscalene Block

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01568463
First received: March 6, 2012
Last updated: March 30, 2012
Last verified: March 2012

March 6, 2012
March 30, 2012
February 2012
December 2012   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The amount of pain and level of satisfaction, [ Time Frame: every 30 minutes starting at post anesthesia care unit admission till 120 minutes ] [ Designated as safety issue: No ]
  • The presence of a Claude-Bernard-Horner Syndrome [ Time Frame: up to 24 hours post operative ] [ Designated as safety issue: Yes ]
  • The presence of hoarseness. [ Time Frame: up to 24 hours post operative ] [ Designated as safety issue: Yes ]
  • The presence of other complications such as hematoma, infection, pneumothorax. [ Time Frame: up to 24 hours post operative and 7 days post op ] [ Designated as safety issue: Yes ]
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
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.
 
Recruiting
25
February 2013
December 2012   (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
Both
18 Years to 85 Years
No
Contact: Kris Abbas, M.D (416)603-5800 ext 6237 kris.abbas@uhn.ca
Canada
 
NCT01568463
11-0806-A
Not Provided
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Richard Brull, MD, FRCPC University of Toronto
University Health Network, Toronto
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP