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

N/ACompletedNCT02054910

University of Alabama at Birmingham5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Pancreatitis

Interventions

Celiac Plexus BlockPROCEDURE

Patients will receive celiac plexus block during endoscopy.

ShamPROCEDURE

Patients will not receive celiac plexus block during endoscopy.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change in Pain Response Over a 6 Month Period of Time Using the VAS Score

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.

Time frame: baseline to 6 months

Secondary Outcomes

Mean Quality of Life Score Between Each Group at 6 Months

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).

Time frame: 6 months post baseline

Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline

the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.

Time frame: baseline to 6 months

Mean Mental State Between Groups Using the Beck's Depression Index at 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.

Time frame: baseline to 6 months

Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure

The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group

Time frame: baseline to 6 months

% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.

Data from ClinicalTrials.gov

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