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Use of Ultrasound in Lower Extremity Blocks.

This study has been completed.
Sponsor:
Collaborator:
University of Toronto
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00221910
First received: September 20, 2005
Last updated: December 4, 2008
Last verified: March 2005
History of Changes

September 20, 2005
December 4, 2008
February 2003
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Complete list of historical versions of study NCT00221910 on ClinicalTrials.gov Archive Site
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Use of Ultrasound in Lower Extremity Blocks.
Does Ultrasound Guidance Improve the Success of Sciatic Nerve Block at the Popliteal Fossa? A Prospective, Randomized, Controlled Trial.

Nerve "freezing" injections of the leg are very useful in providing anesthesia and pain relief for knee and ankle surgery. However, current nerve "freezing" techniques are "blind". As a result, they are not always successful and may cause complications, albeit infrequent.

The objective of the current study is to determine any advantage in performing these "freezing" injections under direct ultrasound guidance, to "visualize" the nerves. We feel that by developing this technique, it will allow us to perform these procedures with greater success and fewer complications.

This study is a randomised controlled trial. Its objective is to compare results and complications between two techniques of nerve localisation for nerve blocks of the lower limb. We have developed a real-time, image guided approach to nerve blocks of the lower extremities in three locations: the femoral nerve in the groin and the sciatic nerve in the buttock and/or popliteal fossa. We have used ultrasound imaging to locate and asess the nerves of the lower extremities and to use it as a real-time guidance for performance of lower extremity blocks in patients undergoing orthopaedic procedures. The results of our previous study will be presented as a case series reporting anatomical appearance of the nerves studied, time for block performance and success rates. In this study we aim to compare these parambeters between standard and ultrasound techniques of lower extremity block, to show any advantage.
Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Regional Anesthesia
Procedure: Ultrasound
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2005
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Inclusion Criteria:

  • English-speaking
  • ASA physical status I-III
  • 18-85 years of age, inclusive
  • 50-110 kg, inclusive
  • 150 cm of height or grater
  • Scheduled for elective foot or ankle surgery

Exclusion Criteria:

  • Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
  • Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
  • Pregnancy
  • Contraindications to, allergies to, and/or past adverse reactions to local anesthetics
  • History of alcohol or drug dependency/abuse
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00221910
UHN02-0771-B
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University Health Network, Toronto
University of Toronto
Principal Investigator: Anahi Perlas, MD University Health Network, Toronto
University Health Network, Toronto
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP