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

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ClinicalTrials.gov Identifier: NCT02054910
Recruitment Status : Completed
First Posted : February 4, 2014
Results First Posted : February 28, 2017
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Charles Mel Wilcox, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Chronic Pancreatitis
Interventions Procedure: Celiac Plexus Block
Procedure: Sham
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description

Celiac Plexus Block will be administered following EUS

Celiac Plexus Block

A celiac plexus block will not be administered for pain management

Sham

Period Title: Overall Study
Started 4 1
Completed 0 0
Not Completed 4 1
Reason Not Completed
Lost to Follow-up             4             1
Arm/Group Title Celiac Plexus Block Sham Total
Hide Arm/Group Description

Celiac Plexus Block will be administered following EUS

Celiac Plexus Block

A celiac plexus block will not be administered for pain management

Sham

Total of all reporting groups
Overall Number of Baseline Participants 4 1 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 1 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
0
   0.0%
3
  60.0%
>=65 years
1
  25.0%
1
 100.0%
2
  40.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 1 participants 5 participants
Female
3
  75.0%
1
 100.0%
4
  80.0%
Male
1
  25.0%
0
   0.0%
1
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 1 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  50.0%
0
   0.0%
2
  40.0%
White
2
  50.0%
1
 100.0%
3
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 1 participants 5 participants
4 1 5
1.Primary Outcome
Title Change in Pain Response Over a 6 Month Period of Time Using the VAS Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description:

Celiac Plexus Block will be administered following EUS

Celiac Plexus Block

A celiac plexus block will not be administered for pain management

Sham

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Mean Quality of Life Score Between Each Group at 6 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description:

Celiac Plexus Block will be administered following EUS

Celiac Plexus Block

A celiac plexus block will not be administered for pain management

Sham

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline
Hide Description the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description:
Celiac Plexus Block will be administered following EUS
A celiac plexus block will not be administered for pain management
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description:
Celiac Plexus Block will be administered following EUS
A celiac plexus block will not be administered for pain management
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were lost to follow up by 6 months; since everyone dropped out at different times before the 6 month point, the data would not be evaluable.
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description:
Celiac Plexus Block will be administered following EUS
A celiac plexus block will not be administered for pain management
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title % of Subjects in Each Group That Are Employed at 6 Months Post Procedure.
Hide Description Subjects will be asked about employment at 6 months post procedure
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description:
Celiac Plexus Block will be administered following EUS
A celiac plexus block will not be administered for pain management
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24-48 hour, 2 week, 6 month, 12 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celiac Plexus Block Sham
Hide Arm/Group Description

Celiac Plexus Block will be administered following EUS

Celiac Plexus Block

A celiac plexus block will not be administered for pain management

Sham

All-Cause Mortality
Celiac Plexus Block Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celiac Plexus Block Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Celiac Plexus Block Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jaypal Ramesh
Organization: University of Alabama at Birmingham
Phone: 205-975-9564
EMail: jramesh@uab.edu
Layout table for additonal information
Responsible Party: Charles Mel Wilcox, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02054910     History of Changes
Other Study ID Numbers: F130822012
First Submitted: January 29, 2014
First Posted: February 4, 2014
Results First Submitted: April 22, 2016
Results First Posted: February 28, 2017
Last Update Posted: February 28, 2017