Clinical trial NCT01568463: Distance for Interscalene Block
Official title: What is the Maximal Effective Distance for Interscalene Block?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regional Anesthesia
Inter Scalene Block
Post Operative Analgesia
Keywords: Inter-scalene Block
Regional Anesthesia
shoulder surgeries
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery)

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.


Eligibility 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

Primary outcomes:
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
timeFrame: 20 mins
Secondary outcomes:
measure: The onset time of sensory and motor block
timeFrame: 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
measure: The proportion of inadequate and failed blocks.
timeFrame: 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
measure: 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.
timeFrame: during the first 24 hours post operative
measure: The amount of pain and level of satisfaction,
timeFrame: every 30 minutes starting at post anesthesia care unit admission till 120 minutes
measure: The presence of a Claude-Bernard-Horner Syndrome
timeFrame: up to 24 hours post operative
measure: The presence of hoarseness.
timeFrame: up to 24 hours post operative
measure: The presence of other complications such as hematoma, infection, pneumothorax.
timeFrame: up to 24 hours post operative and 7 days post op
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Richard Brull, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: