Use of Ultrasound in Lower Extremity Blocks.

NCT ID: NCT00221910

Last Updated: 2008-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2005-03-31

Brief 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.

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.

Conditions

Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Interventions

Ultrasound

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Principal Investigators

Anahi Perlas, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN02-0771-B

Identifier Type: -

Identifier Source: org_study_id