Regional Anesthesia Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
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