Regional AnesthesiaNCT01568463
Distance for Interscalene Block
An observational study of Regional Anesthesia and Inter Scalene Block, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Regional Anesthesia, Inter Scalene Block, Post Operative Analgesia
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to 26 Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery)
Who may be able to join
- ASA physical status I-III
- 18-85 years of age, inclusive
- surgery less than 3 hours
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: What is the Maximal Effective 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.
- Keywords
- Inter-scalene Block, Regional Anesthesia, shoulder surgeries
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 mins
Secondary outcomes (7)
The onset time of sensory and motor block
Measured: 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.
Measured: 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.
Measured: during the first 24 hours post operative
The amount of pain and level of satisfaction,
Measured: every 30 minutes starting at post anesthesia care unit admission till 120 minutes
The presence of a Claude-Bernard-Horner Syndrome
Measured: up to 24 hours post operative
The presence of hoarseness.
Measured: up to 24 hours post operative
The presence of other complications such as hematoma, infection, pneumothorax.
Measured: up to 24 hours post operative and 7 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completion24 Jan 2013
- Study completion26 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Brull, MD, FRCPC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568463
- Sponsor's protocol ID
- 11-0806-A
- Status last verified
- Jan 2018
- First submitted
- 6 Mar 2012
- Last updated
- 10 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Maximal Effective Distance for Interscalene Block?
- ClinicalTrials.gov ID
- NCT01568463
- Acronym / sponsor ID
- 11-0806-A
- Keywords
- Inter-scalene Block, Regional Anesthesia, shoulder surgeries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- 24 Jan 2013 (actual)
- Study completion
- 26 Mar 2014 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery)
Key inclusion criteria (3 listed)
- ASA physical status I-III
- 18-85 years of age, inclusive
- surgery less than 3 hours
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
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
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
The amount of pain and level of satisfaction,
Time frame: every 30 minutes starting at post anesthesia care unit admission till 120 minutes
The presence of a Claude-Bernard-Horner Syndrome
Time frame: up to 24 hours post operative
The presence of hoarseness.
Time frame: up to 24 hours post operative
The presence of other complications such as hematoma, infection, pneumothorax.
Time frame: up to 24 hours post operative and 7 days post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Brull, MD, FRCPC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia and Inter Scalene Block, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 20 mins). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018; AzTrials last refreshed its copy on 27 Oct 2026.