Text Size

Ultrasound Visualization Versus Electrical Nerve Stimulation

This study has been completed.
Sponsor:
Collaborator:
SonoSite, Inc.
Information provided by (Responsible Party):
Nanette Schwann, M.D., Allentown Anesthesia Associates
ClinicalTrials.gov Identifier:
NCT01010412
First received: November 9, 2009
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 9, 2009
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Allentown Anesthesia Associates:
Ultrasound
Nerve blocks
Upper extremity

ClinicalTrials.gov processed this record on May 16, 2013