Ultrasound Visualization Versus Electrical Nerve Stimulation
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|ClinicalTrials.gov Identifier: NCT01010412|
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : August 30, 2012
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 or disease||Intervention/treatment||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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||October 2011|
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)
- 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 ]
- Amount of sedation required for block. (mg of drug) [ Time Frame: 30 minutes after injection ]
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
|United States, Pennsylvania|
|Lehigh Valley Hospital|
|Allentown, Pennsylvania, United States, 18105|
|Principal Investigator:||Nanette Schwann, M.D.||Allentown Anesthesia Associates|