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OpenTrials
Completed

NCT Number: NCT01568463

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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Key information

Conditions

Regional Anesthesia Inter Scalene Block Post Operative Analgesia

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: 20 mins

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. The amount of pain and level of satisfaction,

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

  5. The presence of a Claude-Bernard-Horner Syndrome

    Time frame: up to 24 hours post operative

  6. The presence of hoarseness.

    Time frame: up to 24 hours post operative

  7. The presence of other complications such as hematoma, infection, pneumothorax.

    Time frame: up to 24 hours post operative and 7 days post op

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

What is the Maximal Effective Distance for Interscalene Block?

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 2, 2012
Registry last updated
Jan 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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