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Randomized Controlled Trial of Ultrasound Guided Needle Placement Versus Nerve Stimulation for Coracoid Infraclavicular Brachial Plexus Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00326261
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : December 18, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
Nerve blocks for arm and hand surgery provide many advantages for patients including excellent pain control and reduction in general anesthesia-related adverse effects. Infraclavicular block is possibly the best method for performing regional anesthesia of the arm because of the consistent anesthesia of the whole arm and low incidence of serious adverse effects. Normally the anesthetist uses nerve stimulation to identify nerves supplying the forearm and hand. Recent research has indicated that to improve success from 60% to 79% two types of muscle stimulation must be sought before injection of local anesthetic. This can be time consuming, requires a significant learning process, increases complications and leaves 21% of patients with inadequate anesthesia requiring supplementation or general anesthesia. More recently practitioners have been using ultrasound imaging to direct the needle and watch local anesthetic spread around the nerves. Preliminary reports have documented that this technique is associated with much greater success than the nerve stimulation method. However a good quality study comparing the dual-endpoint infraclavicular technique with an ultrasound-guided technique has not been performed. This randomized study aims to rectify this deficiency by determining if ultrasound-guided infraclavicular block has a significantly greater success than the current standard, dual end-endpoint nerve stimulation technique.

Condition or disease Intervention/treatment
Patients Undergoing Hand Surgery Procedure: Ultrasound compared to dual-endpoint nerve stimulator guided approach. Procedure: Ultrasound

Study Design

Study Type : Observational
Time Perspective: Prospective
Official Title: Randomized Controlled Trial of Ultrasound Guided Needle Placement Versus Nerve Stimulation for Coracoid Infraclavicular Brachial Plexus Block

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326261


Locations
Canada, Ontario
University Health Network, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
The Physicians' Services Incorporated Foundation
Canadian Anesthesiologists' Society
Investigators
Principal Investigator: Colin JL McCartney, MBChB FRCA FCARCSI FRCPC University Health Network, Toronto Western Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00326261     History of Changes
Other Study ID Numbers: 03-0126-AE
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: April 2006