Use of Ultrasound in Lower Extremity Blocks.

Regional Anesthesia Clinical Trial

Official title:

Does Ultrasound Guidance Improve the Success of Sciatic Nerve Block at the Popliteal Fossa? A Prospective, Randomized, Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221910
• Other study ID #: UHN02-0771-B
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: December 4, 2008
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: March 2005
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Regional Anesthesia

Intervention

Procedure:
• Ultrasound

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	University of Toronto

Country where clinical trial is conducted

Canada,