Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade

December 8, 2011 updated by: University Health Network, Toronto

Does Ensuring Circumferential Local Anesthetic Spread Improve the Success of Ultrasound Guided Sciatic Nerve Block at the Popliteal Fossa?

Current practices when performing any peripheral nerve block may or may not involve ensuring circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread can involve several redirections of the needle above and below the nerve, and potentially could result in either more discomfort for the patient or an increased chance of inadvertent direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and less complete blockade. The investigators suspect that by ensuring complete spread around the nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5W 2S8
        • Toronto Western Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. English-speaking
  2. ASA physical status I-III
  3. 18-85 years of age, inclusive
  4. 50-110 kg, inclusive
  5. 150 cm of height or grater
  6. Scheduled for elective foot or ankle surgery

Exclusion Criteria:

  1. Contraindications to sciatic nerve block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the popliteal area)
  2. Significant peripheral neuropathy or neurologic disorder affecting the lower extremity
  3. Pregnancy
  4. Contraindications to, allergies to, and/or past adverse reactions to study medications (local anesthetics, opioid analgesics)
  5. History of alcohol or drug dependency/abuse
  6. History of long term opioid intake
  7. History of significant psychiatric conditions that may affect patient assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Ensuring circumferential spread of local anesthetic around the sciatic nerve.
Procedure: Circumferential spread of local anesthetic
The anesthetist will ensure, under ultrasound guidance, that local anesthetic (1 mL of 1% lidocaine) surrounds the sciatic nerve.
Active Comparator: 2
Single shot injection of local anesthetic near the sciatic nerve will be performed, without ensuring circumferential spread.
Procedure: Non-circumferential spread of local anesthetic
The anesthetist will perform a "single shot" injection of local anesthetic (1 mL of 1% lidocaine) near the sciatic nerve under ultrasound guidance, without ensuring circumferential spread around the nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Onset time of sciatic nerve blockade.
Time Frame: Every 5 minutes for 30 minutes after anesthetic injection
Every 5 minutes for 30 minutes after anesthetic injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Block success, time required to perform block, complications/adverse events, number of needle passes, patient discomfort
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Richard Brull, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

December 9, 2011

Last Update Submitted That Met QC Criteria

December 8, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0728-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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