Distance for Interscalene Block

Regional Anesthesia Clinical Trial

Official title:

What is the Maximal Effective Distance for Interscalene Block?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568463
• Other study ID #: 11-0806-A
• Status: Completed
• Phase: N/A
• First received: March 6, 2012
• Last updated: January 8, 2018
• Start date: February 2012
• Est. completion date: March 26, 2014

Study information

• Verified date: January 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 26, 2014
• Est. primary completion date: January 24, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inter Scalene Block
• Post Operative Analgesia
• Regional Anesthesia

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	The amount of pain and level of satisfaction,		every 30 minutes starting at post anesthesia care unit admission till 120 minutes
Secondary	The presence of a Claude-Bernard-Horner Syndrome		up to 24 hours post operative
Secondary	The presence of hoarseness.		up to 24 hours post operative
Secondary	The presence of other complications such as hematoma, infection, pneumothorax.		up to 24 hours post operative and 7 days post op