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NCT01010412 · ClinicalTrials.gov registry record · Phase 4
Ultrasound Visualization Versus Electrical Nerve Stimulation
A Phase 4 study of Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand, sponsored by Allentown Anesthesia Associates.
- Completed
- Registry status
- Phase 4
- Development phase
- 158
- Enrollment target
- 1
- Study location
NCT01010412 is a Phase 4 study of Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand that has completed, run by Allentown Anesthesia Associates. The registered enrollment target is 158 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01010412, a Phase 4 study of Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand, has completed, sponsored by Allentown Anesthesia Associates.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 158 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- DEVICE Ultrasound (Sonosite Titan T-shaped ultrasound probe)
- DEVICE Electrical Nerve Stimulation (Stimuplex (B Braun) needle)
Study Locations (1)
Pennsylvania
- Lehigh Valley Hospital - Allentown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01010412
The ClinicalTrials.gov registry entry for NCT01010412 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allentown Anesthesia Associates, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand appearing as the primary indexed condition, and to 2 interventions - of which Ultrasound (Sonosite Titan T-shaped ultrasound probe) is the first listed.
NCT01010412 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01010412 about?
NCT01010412 is a clinical study titled "Ultrasound Visualization Versus Electrical Nerve Stimulation". 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 eq...
What is the current status of trial NCT01010412?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 158 participants. The study started on 2009-02. Estimated completion is 2011-10.
What conditions does trial NCT01010412 study?
This clinical trial studies the following conditions: Trauma to the Arm, Shoulder, Elbow, Forearm, or Hand.
What interventions are being tested in trial NCT01010412?
The interventions under investigation include: Ultrasound (Sonosite Titan T-shaped ultrasound probe) (DEVICE), Electrical Nerve Stimulation (Stimuplex (B Braun) needle) (DEVICE).
Who is sponsoring clinical trial NCT01010412?
This trial is sponsored by Allentown Anesthesia Associates, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01010412 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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