Ultrasound Visualization Versus Electrical Nerve Stimulation
Completed · Phase 4
Conditions studied: Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand
In brief
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.
Key facts
- Study ID
- NCT01010412
- Run by
- Allentown Anesthesia Associates
- People needed
- 158
- Starts
- 2009-02-01
- Expected to finish
- 2011-10-01
- Last updated by the study team
- 2012-08-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Peripheral neuropathy
- Coagulopathy
- Anticoagulant treatment that would preclude regional anesthesia
- Local anesthetic allergy
- Infection at the site of injection
Where it is running
- Lehigh Valley Hospital — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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