Regional AnesthesiaNCT00221884
Use of Ultrasound in Upper Extremity Blocks.
A study testing Ultrasound in people with Regional Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Many patients undergoing surgery on their hand receive a form of anesthetic called "axillary brachial plexus block". This involves the injection of local anesthetic (freezing medication) around the nerves that supply the upper limb, which are located in the arm pit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Aug 2002to Aug 2005
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA PS 1-3
- 18 to 80 years of age
- 50 to 100 kg of body weight
- elective upper extremity procedure amenable to brachial plexus block
- estimated surgical time > 1 hr
Who cannot join
- Any medical contraindication to brachial plexus block ( allergy to local anesthetics, coagulopathy, loco-regional malignancy or infection, neurological deficit in the area to be blocked, severe respiratory disease)
- Inability to read, write or speak English
- Chronic pain longer than 6 months
- Chronic opioid use
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Ultrasound Guidance Improve the Success of Brachial Plexus Block? A Prospective, Randomized, Controlled Trial.
Many patients undergoing surgery on their hand receive a form of anesthetic called "axillary brachial plexus block". This involves the injection of local anesthetic (freezing medication) around the nerves that supply the upper limb, which are located in the arm pit. The technique currently used by physicians performing this procedure is far from perfect, and in up to 1 of every 5 patients it does not work well enough to allow surgery, and a different form of anesthetic may need to be used.
In an attempt to improve these results, we have recently developed a new technique, using ultrasound imaging to "see" the nerves prior to giving the injection. Our initial results are very promising, implying that this may be a highly successful and safe approach. The purpose of this study is to determine if this technique is indeed more successful. In order to do that, we will ask 110 patients for their participation. They will be divided in two groups, at random. One group will receive the standard technique (transarterial, using a small needle to find the artery that is close to the nerves). The other group will receive the injection after identifying the nerves with ultrasound imaging. They will all receive the same type of medication, and they will be tested every 5 minutes for half an hour to determine if the block has been successful, according to pre-established criteria. Their pain control will be assessed after the surgery and they will be called 24 hours and 1 week after the surgery to assess their recovery and rule out any possible complications.
Read the detailed description
Ultrasonography has been used successfully to define the anatomy of the brachial plexus in the interscalene, supraclavicular and axillary regions. This is a widely available technology, it is non-invasive, portable, less expensive than other imaging modalities and allows for real time imaging simultaneously with the block procedure.
There are some recent case reports and small case series describing the use of ultrasound to image the brachial plexus and to guide brachial plexus blockade 16,17,18. We have used ultrasound imaging to succesfully identify the brachial plexus and guide needle localization and nerve stimulation in 15 volunteers 19. In these healthy volunteers, we were able to identify the brachial plexus in every subject, at four different anatomical levels : interscalene, supraclavicular, axillary and mid-humeral (see figures). Needle localization and nerve stimulation were also successful in every case. Moreover, preliminary data from an ongoing series at our institution, shows that when ultrasound guidance is used, supraclavicular brachial plexus block can be performed with a high success rate (97%)20.
However, whether ultrasound guidance truly improves success rates when compared to more traditional techniques is still unknown. There has been no randomized controlled trial published to date addressing this question.
- Conditions
- Regional Anesthesia
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2002
- Study completionAug 2005
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, The Physicians' Services Incorporated Foundation
- Investigators
- Vincent WS Chan, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221884
- Sponsor's protocol ID
- UHN02-0430-E
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 5 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasound Guidance Improve the Success of Brachial Plexus Block? A Prospective, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT00221884
- Acronym / sponsor ID
- UHN02-0430-E
- Conditions
- Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, The Physicians' Services Incorporated Foundation
- Study start
- Aug 2002
- Study completion
- Aug 2005 (actual)
- First posted
- 22 Sep 2005 (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.
Many patients undergoing surgery on their hand receive a form of anesthetic called "axillary brachial plexus block". This involves the injection of local anesthetic (freezing medication) around the nerves that supply the upper limb, which are located in the arm pit. The technique currently used by physicians performing this procedure is far from perfect, and in up to 1 of every 5 patients it does not work well enough to allow surgery, and a different form of anesthetic may need to be used.
In an attempt to improve these results, we have recently developed a new technique, using ultrasound imaging to "see" the nerves prior to giving the injection. Our initial results are very promising, implying that this may be a highly successful and safe approach. The purpose of this study is to determine if this technique is indeed more successful. In order to do that, we will ask 110 patients for their participation. They will be divided in two groups, at random. One group will receive the standard technique (transarterial, using a small needle to find the artery that is close to the nerves). The other group will receive the injection after identifying the nerves with ultrasound imaging. They will all receive the same type of medication, and they will be tested every 5 minutes for half an hour to determine if the block has been successful, according to pre-established criteria. Their pain control will be assessed after the surgery and they will be called 24 hours and 1 week after the surgery to assess their recovery and rule out any possible complications.
Detailed description
Ultrasonography has been used successfully to define the anatomy of the brachial plexus in the interscalene, supraclavicular and axillary regions. This is a widely available technology, it is non-invasive, portable, less expensive than other imaging modalities and allows for real time imaging simultaneously with the block procedure.
There are some recent case reports and small case series describing the use of ultrasound to image the brachial plexus and to guide brachial plexus blockade 16,17,18. We have used ultrasound imaging to succesfully identify the brachial plexus and guide needle localization and nerve stimulation in 15 volunteers 19. In these healthy volunteers, we were able to identify the brachial plexus in every subject, at four different anatomical levels : interscalene, supraclavicular, axillary and mid-humeral (see figures). Needle localization and nerve stimulation were also successful in every case. Moreover, preliminary data from an ongoing series at our institution, shows that when ultrasound guidance is used, supraclavicular brachial plexus block can be performed with a high success rate (97%)20.
However, whether ultrasound guidance truly improves success rates when compared to more traditional techniques is still unknown. There has been no randomized controlled trial published to date addressing this question.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA PS 1-3
- 18 to 80 years of age
- 50 to 100 kg of body weight
- elective upper extremity procedure amenable to brachial plexus block
- estimated surgical time > 1 hr
Key exclusion criteria (5 listed)
- Any medical contraindication to brachial plexus block ( allergy to local anesthetics, coagulopathy, loco-regional malignancy or infection, neurological deficit in the area to be blocked, severe respiratory disease)
- Inability to read, write or speak English
- Chronic pain longer than 6 months
- Chronic opioid use
- History of drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 5 Dec 2008.
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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.
Vincent WS Chan, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Regional Anesthesia, 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 5 inclusion and 5 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 5 Dec 2008. 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.
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 5 Dec 2008.