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

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00956683
First received: July 17, 2009
Last updated: August 10, 2009
Last verified: August 2009

July 17, 2009
August 10, 2009
January 2006
August 2008   (final data collection date for primary 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. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00956683 on ClinicalTrials.gov Archive Site
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Dual Endpoint Nerve Stimulation Versus Ultrasound in Infraclavicular Block for Hand Surgery
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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hand Surgery
  • Procedure: Ultrasound Guided Infraclavicular Nerve Block
    Use of Ultrasound to help guide needle placement and local anesthetic injection during infraclavicular nerve block.
  • Procedure: Dual-Endpoint nerve stimulation
    Use of dual-endpoint nerve stimulation to guide needle placement and local anesthetic injection during infraclavicular nerve block.
  • Experimental: Ultrasound
    Ultrasound guided infraclavicular block
    Intervention: Procedure: Ultrasound Guided Infraclavicular Nerve Block
  • Active Comparator: Dual Endpoint Nerve Stimulator
    Nerve stimulator guided dual endpoint infraclavicular block
    Intervention: Procedure: Dual-Endpoint nerve stimulation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
December 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00956683
2004-006
No
Dr. Colin McCartney, University Health Network
University Health Network, Toronto
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Not Provided
University Health Network, Toronto
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP