Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility

Completed · Phase 1

Conditions studied: Dysautonomia

In brief

Dysautonomia is malfunction of the autonomic nervous system. It usually results from overactivity of the sympathetic portion and over-secretion of acetylcholine. Symptoms depend on the organ involved by this sympathetic overstimulation. Involvement of the gastrointestinal system results in chronic dysmotility, nausea, vomiting, food intolerance, weight loss and need for feeding tube placement and/or parenteral feeding. Autonomic celiac ganglia resection has been shown to alleviate symptoms as it interrupts the sympathetic stimulation to the gastrointestinal (GI) system, however there is no pre surgery test to confirm the diagnosis. The investigators' objective is to temporarily block the celiac ganglion with a long acting anesthetic (liposomal bupivacaine). If symptoms abate the diagnosis is confirmed and patient will proceed to surgery.

Key facts

Study ID

NCT04121338

Run by

Johns Hopkins University

People needed

15

Starts

2019-12-09

Expected to finish

2021-05-15

Last updated by the study team

2021-05-19

Who can join

Age: 15 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with dysautonomia-related GI dysmotility, misdiagnosed as having MALS after MALS surgery fails to relieve symptoms
• Patients with known dysautonomia-related dysmotility and related symptoms

You may not qualify if…

• Allergy to liposomal bupivacaine
• Platelets < 50 thousand
• International normalised ration (INR) > 1.7

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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