360
Participants
Start Date
November 17, 2022
Primary Completion Date
September 30, 2025
Study Completion Date
June 30, 2026
Stellate Ganglion Block
After procedure informed consent, the procedure will be done using an ultrasound guided technique with a high frequency (6 to 13 MHz) linear transducer and confirmation of placement by fluoroscopy at sites who do this in clinical practice. The subject will be prepped and draped and placed in supine position in a suite with continuous vital sign monitoring and advanced cardiac life support equipment and IV placement. Local anesthesia with 1% buffered lidocaine will be achieved. After visualization of Chassaignac's tubercle of C6 is identified along with the carotid artery, internal jugular vein and longus colli and capitus muscles, a 25-gauge echo-enhanced needle will be inserted to inject anesthetic over 2 minutes anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle. The needle will be withdrawn and the subject will be monitored for a minimum of 30 minutes.
Sham Stellate Ganglion Block
"The Sham protocol is identical to the SGB protocol except After needle tip confirmation and negative aspiration, normal saline (0.9%) + contrast (unlabeled to keep treater blinded) will be slowly injected over 2 minutes while closely monitoring the subject."
RECRUITING
James A. Haley Veterans' Hospital, Tampa, FL, Tampa
ACTIVE_NOT_RECRUITING
VA Long Beach Healthcare System, Long Beach, CA, Long Beach
RECRUITING
Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis
RECRUITING
VA Salt Lake City Health Care System, Salt Lake City, UT, Salt Lake City
RECRUITING
White River Junction VA Medical Center, White River Junction, VT, White River Junction
RECRUITING
William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison
Analydata, Inc.
INDUSTRY
VA Office of Research and Development
FED