Regional AnesthesiaNCT00221949
Visualizing Peripheral Nerves Using Ultrasound-Guided Approach
An observational study of Regional Anesthesia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Peripheral nerve blocks of the limbs are very useful in providing anesthesia and pain relief for orthopedic procedures in the limbs (elbows, arms, knees, and legs). Considering that current nerve block techniques involve locating the main nerves at the top of the limb and "freezing" those neural structures in order to… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Regional Anesthesia
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 16 health volunteers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Comprehensive Study of the Peripheral Nerves in the Lower Arm and Lower Leg Using an Ultrasound Guided Approach
Peripheral nerve blocks of the limbs are very useful in providing anesthesia and pain relief for orthopedic procedures in the limbs (elbows, arms, knees, and legs). Considering that current nerve block techniques involve locating the main nerves at the top of the limb and "freezing" those neural structures in order to provide pain relief to the rest of the extremity, a comprehensive study of the nerves located lower in the limbs is needed. This study provides a step in the direction of the development of techniques for advanced nerve blockade that target nerve structures lower in the limbs to provide precise pain relief rather than widespread numbness.
The objective of the study aims to use direct ultrasound guidance to develop a comprehensive examination and identification of the peripheral nerves in the lower region of the upper and lower limbs (arms and legs). In a sense, this process allows us to "visualize" the nerves. In the future, with the experience of visualizing these nerves with the ultrasound machine, we can develop techniques that may allow us to perform anesthetic blockade with greater success and fewer complications.
An ultrasound exam will be performed on 8 healthy volunteers to view the peripheral nerves in the lower arm in three locations: the elbow area, the wrist area, and the midpoint of the arm between the elbow and the wrist. A set of 8 healthy patients will be given an ultrasound exam to view the peripheral nerves located in the lower leg by imaging three locations: the knee area, the ankle area, and the midpoint of the leg between the knee and the ankle. The appropriate nerves will be identified by ultrasound and images will be captured and recorded for further corroboration. The group of 16 subjects will allow for varied observations of anatomical positions of neural and vascular structures, while keeping the sample size fairly small. No injections will be made at any time during this study.
Read the detailed description
The nerves of the upper extremities derive from the brachial plexus, and likewise, the nerves of the lower extremities derive from the lumbo-sacral plexus (1). In clinical practice, nerve blocks are commonly performed to provide postoperative analgesia after orthopedic procedures involving the upper and lower extremities (2,3). They may also be used as a sole anesthetic technique during surgery.
The two main concerns with upper and lower extremity blocks, as with other regional anesthetic techniques, are technical failure and block related complications. The most cited complications are bleeding from inadvertent arterial or venous puncture, intravascular injection of local anesthetic resulting in central nervous system or cardiac toxicity, and intraneural injection of local anesthetic resulting in peripheral neuropathy of varying degrees (4,5).
Both technical failures and complications are related at least in part, to the fact that all the techniques used to date are blind. Anatomical landmarks (as described in the literature) and nerve stimulators are helpful ways to localize the nerves to be blocked.
We believe that the best approach to improve success rate and minimize complications of peripheral nerve blocks is to use image-guided techniques. In the last few years, different imaging modalities have been used to evaluate the peripheral nerves of the upper and lower extremities. Studies currently underway at our institution seek to develop a comprehensive technique for upper and lower extremity nerve blocks. However, this involves anesthetizing from the top of the limb in order to numb the entire extremity. More research is needed to derive a comprehensive examination of the peripheral nerves found in the lower regions of the upper and lower extremities. While CT scanning and MRI are probably the techniques of choice when it comes to diagnosing nerve pathology, they would not be useful in the perioperative setting due to the lack of portability and the inability to perform real time imaging simultaneously with nerve block performance (6,7).
Ultrasound has been used successfully in the last few years to image the peripheral nerves of the upper extremity (8,9). The development of higher frequency ultrasound probes, and higher imaging resolution has made it possible to localize and evaluate peripheral nerves with ultrasound, something that was not possible only 10-15 years ago. The anatomy of the brachial plexus has been described by a number of authors. There have been some preliminary studies looking into the possibility of developing a real-time ultrasound guided technique for upper extremity blocks (10, 11, 12, 13,). Studies performed at our institution involving refining a technique for upper extremity blocks show encouraging results.
It is clear, that ultrasound can be used to a further degree of sophistication in order to image peripheral nerves in the lower parts of the upper and lower limbs. As expressed by many of the referenced authors, ultrasound use is likely to increase significantly in the coming years, both in the areas of diagnostic radiology and clinical regional anesthesia, to guide nerve blocks (17). As a result, it is evident that the development of an advanced technique for anesthetic blockade - which targets a precise location or nerve - can derive from this knowledge and recognition of peripheral nerves located in the lower parts of limbs. To this date, nonetheless, there is no systematic evaluation of the nerves located in the lower regions of the upper and lower limbs by ultrasound.
- 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.
UltrasoundDevice
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)
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
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Vincent Chan, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221949
- Sponsor's protocol ID
- UHN05-0491-AE
- Status last verified
- Aug 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
- Development of a Comprehensive Study of the Peripheral Nerves in the Lower Arm and Lower Leg Using an Ultrasound Guided Approach
- ClinicalTrials.gov ID
- NCT00221949
- Acronym / sponsor ID
- UHN05-0491-AE
- Conditions
- Regional Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- 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.
Peripheral nerve blocks of the limbs are very useful in providing anesthesia and pain relief for orthopedic procedures in the limbs (elbows, arms, knees, and legs). Considering that current nerve block techniques involve locating the main nerves at the top of the limb and "freezing" those neural structures in order to provide pain relief to the rest of the extremity, a comprehensive study of the nerves located lower in the limbs is needed. This study provides a step in the direction of the development of techniques for advanced nerve blockade that target nerve structures lower in the limbs to provide precise pain relief rather than widespread numbness.
The objective of the study aims to use direct ultrasound guidance to develop a comprehensive examination and identification of the peripheral nerves in the lower region of the upper and lower limbs (arms and legs). In a sense, this process allows us to "visualize" the nerves. In the future, with the experience of visualizing these nerves with the ultrasound machine, we can develop techniques that may allow us to perform anesthetic blockade with greater success and fewer complications.
An ultrasound exam will be performed on 8 healthy volunteers to view the peripheral nerves in the lower arm in three locations: the elbow area, the wrist area, and the midpoint of the arm between the elbow and the wrist. A set of 8 healthy patients will be given an ultrasound exam to view the peripheral nerves located in the lower leg by imaging three locations: the knee area, the ankle area, and the midpoint of the leg between the knee and the ankle. The appropriate nerves will be identified by ultrasound and images will be captured and recorded for further corroboration. The group of 16 subjects will allow for varied observations of anatomical positions of neural and vascular structures, while keeping the sample size fairly small. No injections will be made at any time during this study.
Detailed description
The nerves of the upper extremities derive from the brachial plexus, and likewise, the nerves of the lower extremities derive from the lumbo-sacral plexus (1). In clinical practice, nerve blocks are commonly performed to provide postoperative analgesia after orthopedic procedures involving the upper and lower extremities (2,3). They may also be used as a sole anesthetic technique during surgery.
The two main concerns with upper and lower extremity blocks, as with other regional anesthetic techniques, are technical failure and block related complications. The most cited complications are bleeding from inadvertent arterial or venous puncture, intravascular injection of local anesthetic resulting in central nervous system or cardiac toxicity, and intraneural injection of local anesthetic resulting in peripheral neuropathy of varying degrees (4,5).
Both technical failures and complications are related at least in part, to the fact that all the techniques used to date are blind. Anatomical landmarks (as described in the literature) and nerve stimulators are helpful ways to localize the nerves to be blocked.
We believe that the best approach to improve success rate and minimize complications of peripheral nerve blocks is to use image-guided techniques. In the last few years, different imaging modalities have been used to evaluate the peripheral nerves of the upper and lower extremities. Studies currently underway at our institution seek to develop a comprehensive technique for upper and lower extremity nerve blocks. However, this involves anesthetizing from the top of the limb in order to numb the entire extremity. More research is needed to derive a comprehensive examination of the peripheral nerves found in the lower regions of the upper and lower extremities. While CT scanning and MRI are probably the techniques of choice when it comes to diagnosing nerve pathology, they would not be useful in the perioperative setting due to the lack of portability and the inability to perform real time imaging simultaneously with nerve block performance (6,7).
Ultrasound has been used successfully in the last few years to image the peripheral nerves of the upper extremity (8,9). The development of higher frequency ultrasound probes, and higher imaging resolution has made it possible to localize and evaluate peripheral nerves with ultrasound, something that was not possible only 10-15 years ago. The anatomy of the brachial plexus has been described by a number of authors. There have been some preliminary studies looking into the possibility of developing a real-time ultrasound guided technique for upper extremity blocks (10, 11, 12, 13,). Studies performed at our institution involving refining a technique for upper extremity blocks show encouraging results.
It is clear, that ultrasound can be used to a further degree of sophistication in order to image peripheral nerves in the lower parts of the upper and lower limbs. As expressed by many of the referenced authors, ultrasound use is likely to increase significantly in the coming years, both in the areas of diagnostic radiology and clinical regional anesthesia, to guide nerve blocks (17). As a result, it is evident that the development of an advanced technique for anesthetic blockade - which targets a precise location or nerve - can derive from this knowledge and recognition of peripheral nerves located in the lower parts of limbs. To this date, nonetheless, there is no systematic evaluation of the nerves located in the lower regions of the upper and lower limbs by ultrasound.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 16 health volunteers
Key exclusion criteria (0 listed)
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 | Device | – |
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 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?
An observational study of 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 1 inclusion and 0 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; AzTrials last refreshed its copy on 2 Nov 2026.