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Ultrasound Visualization Versus Electrical Nerve Stimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01010412
First Posted: November 10, 2009
Last Update Posted: August 30, 2012
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.
Collaborator:
SonoSite, Inc.
Information provided by (Responsible Party):
Nanette Schwann, M.D., Allentown Anesthesia Associates
  Purpose

Hypothesis and Specific Aims:

The investigators hypothesize that ultrasound (US) visualization is as effective as nerve stimulation (NS) for identification of peripheral nervous structures and may be associated with less trauma and patient discomfort. Specifically, the investigators believe that equivalent rates of surgical anesthesia are achievable with non-invasive ultrasonic needle guidance in comparison to needle guidance by intensity of motor fiber response to intermittent electrical nerve stimulation. Specifically, the number of needle sticks to identify the brachial plexus and total time to plexus sheath injection may be reduced while achieving similar efficacy rates. The investigators hypothesize that similar composite safety and efficacy endpoints but improved patient satisfaction and acceptance will favor US over NS guidance of nerve blocks indicated for surgery on the extremity surgery. However, the investigators believe that an economic assessment based upon capital hardware investment, operating room utilization, total block time, and pay for performance patient satisfaction metrics require examination prior to assimilation of new technology into clinical practice.


Condition Intervention Phase
Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand Device: Ultrasound (Sonosite Titan T-shaped ultrasound probe) Device: Electrical Nerve Stimulation (Stimuplex (B Braun) needle) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound Visualization v. Electrical Nerve Stimulation for the Safety and Effectiveness of Interscalene/Axillary Nerve Block in Upper Extremity Surgery: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Nanette Schwann, M.D., Allentown Anesthesia Associates:

Primary Outcome Measures:
  • Incidence of Successful Block: defined by avoidance of General Anesthesia (which will be documented in the medical record as such) [ Time Frame: 30 minutes after injection ]

Secondary Outcome Measures:
  • Amount of sedation required for block. (mg of drug) [ Time Frame: 30 minutes after injection ]

Enrollment: 158
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound
Ultrasound guided nerve localization through direct visualization of the nerves and surrounding structures.
Device: Ultrasound (Sonosite Titan T-shaped ultrasound probe)
Ultrasonography will allow direct visualization of nerves. As local anesthetic is injected, it can be seen surrounding the nerve.
Other Name: Sonosite Titan T-shaped ultrasound probe
Active Comparator: Nerve Stimulation
Standard of Care
Device: Electrical Nerve Stimulation (Stimuplex (B Braun) needle)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients older than 18 years of age at the time of screening
  • ASA Class I - IV, undergoing unilateral elective surgical procedure involving the shoulder, arm, elbow, forearm, or hand
  • Planned interscalene block

Exclusion Criteria:

  • Peripheral neuropathy
  • Coagulopathy
  • Anticoagulant treatment that would preclude regional anesthesia
  • Local anesthetic allergy
  • Infection at the site of injection
  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): NCT01010412


Locations
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18105
Sponsors and Collaborators
Allentown Anesthesia Associates
SonoSite, Inc.
Investigators
Principal Investigator: Nanette Schwann, M.D. Allentown Anesthesia Associates
  More Information

Publications:
Responsible Party: Nanette Schwann, M.D., MD, Allentown Anesthesia Associates
ClinicalTrials.gov Identifier: NCT01010412     History of Changes
Other Study ID Numbers: UVVENS
First Submitted: November 9, 2009
First Posted: November 10, 2009
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Nanette Schwann, M.D., Allentown Anesthesia Associates:
Ultrasound
Nerve blocks
Upper extremity