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

NCT00956683 | Completed

• 1 other identifier: 2004-006
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Surgery

Keywords

infraclavicular nerve block ultrasound dual endpoint stimulation

Outcome Measures

Primary Outcomes (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.

Study Arms (2)

Ultrasound

EXPERIMENTAL

Ultrasound guided infraclavicular block

Procedure: Ultrasound Guided Infraclavicular Nerve Block

Dual Endpoint Nerve Stimulator

ACTIVE COMPARATOR

Nerve stimulator guided dual endpoint infraclavicular block

Procedure: Dual-Endpoint nerve stimulation

Interventions

Ultrasound Guided Infraclavicular Nerve Block PROCEDURE

Use of Ultrasound to help guide needle placement and local anesthetic injection during infraclavicular nerve block.

Ultrasound

Dual-Endpoint nerve stimulation PROCEDURE

Use of dual-endpoint nerve stimulation to guide needle placement and local anesthetic injection during infraclavicular nerve block.

Dual Endpoint Nerve Stimulator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective upper limb surgery at or below the elbow.
• Patients aged \>18 and \<80 years
• ASA I-III
• BMI\<35

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Colin McCartney

Toronto, Ontario, M5T 2S8, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: August 11, 2009
• Study Start: January 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 11, 2009

Record last verified: 2009-08

Locations

CA (1)