At a glance
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Evaluating the Effectiveness of Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Post-Acute Sequelae of SARS-CoV-2 (PASC)
In Brief
A Phase 1 clinical trial evaluating stellate ganglion block with 0.5% bupivacaine for Post Acute COVID-19 Syndrome and 14 related conditions. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.
Study Details
Timeline
Interventions
The stellate ganglion block is being done on both sides of the neck. The stellate ganglion block will be performed on the right side at the first visit. The procedure will be repeated on the left side one week after the first injection. This study is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug. Similar to a phase 1 clinical trial, the main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms. As a general rule, phase 1 studies require a low number of patients, typically 12-20 subjects. There is considerable uncertainty regarding long COVID as a disease state, so data from even small numbers of patients in a well-designed clinical trial will make steps towards reducing that uncertainty.