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

NCT04121338 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB00198738
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysautonomia

Keywords

celiac ganglion block; resection; bowel dysmotility

Outcome Measures

Primary Outcomes (2)

• Amount of solid food intake by mouth per day

  Over the 2 days post Celiac Ganglion block, the investigators will monitor the patient (outpatient) for amount of solid food intake (grams) per day.

  2 days post celiac ganglion block

• Change in abdominal pain as assessed by patient reported pain on scale 1-10 (10 worse)

  Patients with GI involvement of dysautonomia have abdominal pain which is worse with solid food intake. The patient's ability to take solid food without pain will be evaluated on scale 1-10 with 10 being worse pain.

  Baseline and 2 days post-celiac ganglion block

Secondary Outcomes (2)

• Number of episodes of nausea/vomiting per day

  2 days post celiac ganglion block

• Change in amount of analgesic medications used

  Baseline and 2 days post celiac ganglion block

Study Arms (1)

Test group

EXPERIMENTAL

10 patients with presumptive diagnosis of dysautonomia with chronic nausea, vomiting and food intolerance

Procedure: Celiac ganglion block; Drug: Liposomal bupivacaine

Interventions

Celiac ganglion block PROCEDURE

The celiac ganglion block will be performed under CT guidance and with the patent under moderate sedation. With the patient prone the back will be prepped and draped sterility. Under CT guidance two 22 gauge needles will be placed with the tips on either side of the celiac artery. This is the location of the celiac ganglia. Liposomal bupivacaine will then be injected in that location. Maximum dose is 133 mg for 75 kg person. For lower weight patients, dose will be weight based. Then patient will be observed for 1-2 hours post procedure and then discharged to home

Test group

Liposomal bupivacaine DRUG

Liposomal bupivacaine will then be injected in that location. Maximum dose is 133 mg for 75 kg person. For lower weight patients, dose will be weight based.

Also known as: Exparel

Test group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Christos Georgiades, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Since this is a single arm study, no masking will be performed
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 10 patients with chronic GI dysmotility, chronic nausea/vomiting and feeding intolerance requiring G-J feeding and considered for Celiac Ganglion resection

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: December 9, 2019
• Primary Completion: May 15, 2021
• Study Completion: May 15, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)