Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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
Regional Anesthesia
Inter Scalene Block
Post Operative Analgesia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: What is the Maximal Effective Distance for Interscalene Block?

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568463

Contacts
Contact: Kris Abbas, M.D (416)603-5800 ext 6237 kris.abbas@uhn.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Richard Brull, MD, FRCPC University of Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01568463     History of Changes
Other Study ID Numbers: 11-0806-A
Study First Received: March 6, 2012
Last Updated: March 30, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Inter-scalene Block
Regional Anesthesia
shoulder surgeries

ClinicalTrials.gov processed this record on November 24, 2014