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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Canada1 site
  • University Health Network

    Toronto, Ontario, M5T 2S8

Other trials in Canada

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.

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.

  1. First posted22 Sep 2005 (estimated)

Resources

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)
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

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.

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