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
  Purpose

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 Intervention
Hand Surgery
Procedure: Ultrasound Guided Infraclavicular Nerve Block
Procedure: Dual-Endpoint nerve stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Comparing Dual Endpoint Nerve Stimulation With Ultrasound-guided Infraclavicular Block for Hand Surgery.

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Enrollment: 106
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956683

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

No publications provided

Responsible Party: Dr. Colin McCartney, University Health Network
ClinicalTrials.gov Identifier: NCT00956683     History of Changes
Other Study ID Numbers: 2004-006
Study First Received: July 17, 2009
Last Updated: August 10, 2009
Health Authority: Canada: Canadian REB

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

ClinicalTrials.gov processed this record on July 29, 2014