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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00956683
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : August 11, 2009
Information provided by:
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hand Surgery Procedure: Ultrasound Guided Infraclavicular Nerve Block Procedure: Dual-Endpoint nerve stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Comparing Dual Endpoint Nerve Stimulation With Ultrasound-guided Infraclavicular Block for Hand Surgery.
Study Start Date : January 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing elective upper limb surgery at or below the elbow.
  • Patients aged >18 and <80 years
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00956683

Canada, Ontario
Colin McCartney
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto

Responsible Party: Dr. Colin McCartney, University Health Network Identifier: NCT00956683     History of Changes
Other Study ID Numbers: 2004-006
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009

Keywords provided by University Health Network, Toronto:
infraclavicular nerve block ultrasound dual endpoint stimulation