Distance for Interscalene Block

NCT01568463 | Completed

• 1 other identifier: 11-0806-A
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia; Inter Scalene Block; Post Operative Analgesia

Keywords

Inter-scalene Block; Regional Anesthesia; shoulder surgeries

Outcome Measures

Primary Outcomes (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 Outcomes (7)

• 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

• 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

• 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

• The amount of pain and level of satisfaction,

  every 30 minutes starting at post anesthesia care unit admission till 120 minutes

• The presence of a Claude-Bernard-Horner Syndrome

  up to 24 hours post operative

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ASA physical status I-III
• years of age, inclusive
• surgery less than 3 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Study Officials

• Richard Brull, MD, FRCPC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: April 2, 2012
• Study Start: February 1, 2012
• Primary Completion: January 24, 2013
• Study Completion: March 26, 2014
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

CA (1)