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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02399800 |
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Date of registration:
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11/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Celiac Plexus Block for Chronic Pancreatitis RCT
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Scientific title:
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Prospective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic Pancreatitis |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02399800 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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James Buxbaum, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Los Angels County Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Presentation with upper abdominal pain suggestive of pancreatitis who are undergoing
EUS for evaluation
- M ANNHEIM severity index of 6 or greater to be included
- Intermittent episodes of pain>3 requiring opiate medication
Exclusion Criteria:
- Patients who have allergic reactions to steroids or bupivacaine
- INR >1.6
- platelets <75
- decompensated cirrhosis
- incarcerated
- <18 years old
- unable to give informed consent
- peptic ulcer disease
- ongoing substance or alcohol use
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pancreatitis
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Pancreatitis, Chronic
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Intervention(s)
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Procedure: Celiac Block with triamcinolone and bupivicaine
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Drug: Intra Plexus Triamcinolone and Bupivicaine Injection
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Procedure: No Celiac Block
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Primary Outcome(s)
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Long Term CHANGE in Pain Scores
[Time Frame: 24 weeks]
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Secondary Outcome(s)
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Hospital re-admission
[Time Frame: 24 weeks]
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CHANGE Pain medication requirements
[Time Frame: 24 weeks]
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Procedure Complications
[Time Frame: 2 weeks]
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Secondary ID(s)
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HS-14-00134
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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