Dual Endpoint Nerve Stimulation Versus Ultrasound in Infraclavicular Block for Hand Surgery

August 10, 2009 updated by: University Health Network, Toronto

A Randomized Controlled Study Comparing Dual Endpoint Nerve Stimulation With Ultrasound-guided Infraclavicular Block for Hand Surgery.

Current best practice for performance of infraclavicular block dictates the use of a dual-endpoint nerve stimulation technique that still only results in a 79% success rate. Use of an ultrasound-guided technique has the potential to significantly improve success. A randomized, controlled study to evaluate this area remains to be performed and is required to demonstrate to anesthesiologists that an ultrasound-guided approach should supersede nerve stimulation as the technique of choice for infraclavicular block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

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, M5T 2S8
        • Colin McCartney

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing elective upper limb surgery at or below the elbow.
  • Patients aged >18 and <80 years
  • ASA I-III
  • BMI<35

Exclusion Criteria:

  • Inability to read, write or speak English. (This is necessary because subjects will have to follow detailed instructions to allow testing of motor and sensory function. It is not feasible to have an interpreter present in the block room during performance of these procedures)
  • Contraindication to brachial plexus block
  • Existing neurological deficit in the area to be blocked
  • Known loco-regional malignancy or infection
  • Coagulopathy
  • Allergy to local anesthetic agents.
  • Chest or shoulder deformities
  • Severe respiratory disease
  • Healed but dislocated clavicle fracture

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound
Ultrasound guided infraclavicular block
Procedure: Ultrasound Guided Infraclavicular Nerve Block
Use of Ultrasound to help guide needle placement and local anesthetic injection during infraclavicular nerve block.
Active Comparator: Dual Endpoint Nerve Stimulator
Nerve stimulator guided dual endpoint infraclavicular block
Procedure: Dual-Endpoint nerve stimulation
Use of dual-endpoint nerve stimulation to guide needle placement and local anesthetic injection during infraclavicular nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare ultrasound-guided infraclavicular block with conventional dual-endpoint nerve stimulator guided infraclavicular block with regards to block success, ease of nerve localization, speed of onset, duration of block and complications.

Collaborators and Investigators

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

Sponsor

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

January 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 17, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2009

Last Update Submitted That Met QC Criteria

August 10, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2004-006

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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