Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility
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|ClinicalTrials.gov Identifier: NCT04121338|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dysautonomia||Procedure: Celiac ganglion block Drug: Liposomal bupivacaine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||10 patients with chronic GI dysmotility, chronic nausea/vomiting and feeding intolerance requiring G-J feeding and considered for Celiac Ganglion resection|
|Masking:||None (Open Label)|
|Masking Description:||Since this is a single arm study, no masking will be performed|
|Official Title:||Prospective Single-Arm Pilot Study for CT-Guided, Temporary Celiac Ganglion Block as a Test Before Celiac Ganglion Resection for Dysautonomia-Related Bowel Dysmotility|
|Actual Study Start Date :||December 9, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Experimental: Test group
10 patients with presumptive diagnosis of dysautonomia with chronic nausea, vomiting and food intolerance
Procedure: Celiac ganglion block
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
Drug: Liposomal bupivacaine
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.
Other Name: Exparel
- Amount of solid food intake by mouth per day [ Time Frame: 2 days post celiac ganglion block ]Over the 2 days post Celiac Ganglion block, the investigators will monitor the patient (outpatient) for amount of solid food intake (grams) per day.
- Change in abdominal pain as assessed by patient reported pain on scale 1-10 (10 worse) [ Time Frame: Baseline and 2 days post-celiac ganglion block ]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.
- Number of episodes of nausea/vomiting per day [ Time Frame: 2 days post celiac ganglion block ]The frequency of nausea/vomiting will be tabulated.
- Change in amount of analgesic medications used [ Time Frame: Baseline and 2 days post celiac ganglion block ]Patients with GI dysautonomia have chronic abdominal pain and take almost daily analgesic medication. The investigators shall evaluate the use of analgesic medication for the duration of the Celiac Ganglion block.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121338
|Contact: CHRISTOS GEORGIADES, MD PHDemail@example.com|
|Contact: Beatriz Kohlerfirstname.lastname@example.org|
|Principal Investigator:||Christos Georgiades, MD, PhD||Johns Hopkins University|