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
  Purpose

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.


Condition Intervention
Regional Anesthesia
Procedure: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Does Ultrasound Guidance Improve the Success of Sciatic Nerve Block at the Popliteal Fossa? A Prospective, Randomized, Controlled Trial.

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

Study Start Date: February 2003
Study Completion Date: March 2005
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00221910

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5T2S8
Sponsors and Collaborators
University Health Network, Toronto
University of Toronto
Investigators
Principal Investigator: Anahi Perlas, MD University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221910     History of Changes
Other Study ID Numbers: UHN02-0771-B
Study First Received: September 20, 2005
Last Updated: December 4, 2008
Health Authority: Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on August 19, 2014