CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis

Not Applicable

Completed

Brief Summary: This study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.

Detailed Description: The purpose of this study is to assess pain response to EUS guided celiac plexus block treatment compared to no treatment. The Visual Analog Scale (VAS) is the primary measure. Secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of EUS-CPB on overall mental state using the Beck's Depression Index, and to assess the effect of EUS-CBP on health care utilization and on employment.

Recruitment & Eligibility

Inclusion Criteria

All patients referred to UAB Endoscopy Unit for with known chronic pancreatitis
Patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi).

Exclusion Criteria

Age <19 years
Unable to safely undergo EUS for any reason
Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
Unable to consent
Non-English speaking patients.
Previously undergone CPB
Pregnancy and Breast feeding
Patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts.
Previous pancreatic surgery
Previous pseudocyst drainage
Other documented causes of abdominal pain.

Arm && Interventions

Group	Intervention	Description
Sham	Sham	A celiac plexus block will not be administered for pain management
Celiac Plexus Block	Celiac Plexus Block	Celiac Plexus Block will be administered following EUS

Primary Outcome Measures

Name	Time	Method
Change in Pain Response Over a 6 Month Period of Time Using the VAS Score	baseline to 6 months	Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.

Secondary Outcome Measures

Name	Time	Method
Mean Quality of Life Score Between Each Group at 6 Months	6 months post baseline	The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).
Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline	baseline to 6 months	the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.	baseline to 6 months	The Beck's Depression scale was used to indicate subject's depression: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure	baseline to 6 months	The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group
% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.	baseline to 6 months	Subjects will be asked about employment at 6 months post procedure