drugset / Trial / NCT04121338

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

NCT04121338

Phase 1 Completed 15 enrolled Johns Hopkins University
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2019-12-09
Primary completion
2021-05-15
Completion
2021-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 133 mg

Indications