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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 17, 2009
Last Updated Date	August 10, 2009
Start Date ^ICMJE	January 2006
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 10, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00956683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dual Endpoint Nerve Stimulation Versus Ultrasound in Infraclavicular Block for Hand Surgery
Official Title ^ICMJE	A Randomized Controlled Study Comparing Dual Endpoint Nerve Stimulation With Ultrasound-guided Infraclavicular Block for Hand Surgery.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hand Surgery
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	106
Completion Date	December 2008
Primary Completion Date	August 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT00956683
Other Study ID Numbers ^ICMJE	2004-006
Has Data Monitoring Committee	No
Responsible Party	Dr. Colin McCartney, University Health Network
Study Sponsor ^ICMJE	University Health Network, Toronto
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Health Network, Toronto
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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