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

• Sponsor: University Health Network, Toronto (Other)
• Overall Status: Completed
• CT.gov ID: NCT00956683
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Surgery	Procedure: Ultrasound Guided Infraclavicular Nerve Block; Procedure: Dual-Endpoint nerve stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Study Comparing Dual Endpoint Nerve Stimulation With Ultrasound-guided Infraclavicular Block for Hand Surgery.
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Colin McCartney	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

• University Health Network, Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00956683
• Other Study ID Numbers: 2004-006
• First Posted: Aug 11, 2009
• Last Update Posted: Aug 11, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: infraclavicular nerve block ultrasound dual endpoint stimulation

Study Results

No Results Posted as of Aug 11, 2009