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Use of Ultrasound in Upper Extremity Blocks.

This study has been completed.
Sponsor:
Collaborators:
Canadian Anesthesiologists' Society
The Physicians' Services Incorporated Foundation
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00221884
First received: September 20, 2005
Last updated: December 4, 2008
Last verified: September 2005
  Purpose

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.


Condition Intervention
Regional Anesthesia
Procedure: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Does Ultrasound Guidance Improve the Success of Brachial Plexus Block? A Prospective, Randomized, Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Study Start Date: August 2002
Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion criteria

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221884

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
Canadian Anesthesiologists' Society
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Vincent WS Chan, MD University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221884     History of Changes
Other Study ID Numbers: UHN02-0430-E
Study First Received: September 20, 2005
Last Updated: December 4, 2008
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on November 25, 2014