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Ultrasound Visualization Versus Electrical Nerve Stimulation

NCT01010412 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2012-08-30

No results posted yet for this study

Summary

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.

Conditions

  • Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand

Interventions

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.

DEVICE

Electrical Nerve Stimulation (Stimuplex (B Braun) needle)

Sponsors & Collaborators

  • SonoSite, Inc.

    collaborator INDUSTRY

  • Allentown Anesthesia Associates

    lead OTHER

Principal Investigators

  • Nanette Schwann, M.D. · Allentown Anesthesia Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-03-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01010412 on ClinicalTrials.gov