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

Hand Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956683
• Other study ID #: 2004-006
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: August 10, 2009
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian REB
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Surgery

Intervention

Procedure:
• Ultrasound Guided Infraclavicular Nerve Block
Use of Ultrasound to help guide needle placement and local anesthetic injection during infraclavicular nerve block.
• Dual-Endpoint nerve stimulation
Use of dual-endpoint nerve stimulation to guide needle placement and local anesthetic injection during infraclavicular nerve block.

Locations

Country	Name	City	State
Canada	Colin McCartney	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No